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CURRICULUM VITAE
ELAINE H. MORRATO
CURRENT POSITION
UNIVERSITY OF COLORADO ANSCHUTZ MEDICAL CAMPUS
Primary Appointment
Colorado School of Public Health, Interim Dean and Associate Dean for Public Health Practice
Associate Professor (with tenure), Department of Health Systems, Management and Policy
Secondary Appointments
School of Medicine, Department of Pediatrics
Skaggs School of Pharmacy and Pharmaceutical Sciences, Department of Clinical Pharmacy
13001 East 19th Place, Room E3311
Mail Stop B119
Aurora, CO 80045-0508
303-724-7304 (phone)
303-724-4495 (fax)
Email: [email protected]
EDUCATION
2004-2006 Pharmaceutical Outcomes Research Fellowship, Department of Clinical Pharmacy,
School of Pharmacy, University of Colorado Denver, CO
Advisors: Robert Valuck, PhD and Patrick Sullivan, PhD
2006 Dr.P.H., General Epidemiology, The Johns Hopkins University, The Johns Hopkins
Bloomberg School of Public Health, Baltimore, MD. Dissertation: Impact of
nefazodone (Serzone®) hepatic risk minimization recommendations: a case study
evaluation of an FDA Boxed Warning.
Advisor: Manning Feinleib, MD DrPH
2003 M.P.H., Epidemiology, The Johns Hopkins University, The Johns Hopkins Bloomberg
School of Public Health, Baltimore, MD. Masters Capstone Project: FDA pediatric drug
policy: Characteristics of drugs granted exclusivity.
Advisor: Manning Feinleib, MD DrPH
1988 B.S. (Honors) summa cum laude, Biology/Biochemistry, Purdue University, West
Lafayette, IN. Honors thesis: Spectral analysis of thermodynamic properties in non-
Watson-Crick base pairing and DNA secondary structure
CONTINUING EDUCATION
2014-2015 Leadership for Innovative Team Science (LITeS), a select senior and mid-career faculty
development program, Colorado Clinical & Translational Sciences Institute, Aurora, CO.
2012 Kellogg Executive Education Program, Marketing and Sales Certificate, Kellogg School
of Management, Northwestern University, Chicago, IL.
2010 Institute on Systems Science and Health (ISSH), Social Network Analysis Track,
Mailman School of Public Health, Columbia University, New York, NY. Sponsored by
the National Institutes of Health and the Centers for Disease Control and Prevention.
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ACADEMIC APPOINTMENTS AND POSITIONS
APPOINTMENTS
University of Colorado Anschutz Medical Campus, Aurora, CO
2012- Associate Professor (with tenure), Department of Health Systems, Management & Policy,
Colorado School of Public Health
2009 - 2012 Assistant Professor, Department of Health Systems, Management & Policy, Colorado
School of Public Health
2006 - 2009 Assistant Professor, Division of General Pediatrics, Department of Pediatrics, School of
Medicine
POSITIONS
University of Colorado Anschutz Medical Campus, Aurora, CO
2016- Interim Dean, Colorado School of Public Health
2016- Postdoctoral Research Faculty, Developmental Psychobiology Research Group (DPRG)
T32 Training Program, MH015442, Development of Psychopathology, Psychobiology &
Behavior, Mark L. Laudenslager, Program Director.
2015- Associate Dean for Public Health Practice, Colorado School of Public Health
2015-2016 Co-Director, Dissemination and Implementation Science Program, Adult and Child
Consortium for Health Outcomes Research and Delivery Science (ACCORDS), School
of Medicine
2010-2014 Associate Director, Children’s Outcomes Research (COR) Program, School of Medicine
2011-2013 Comparative Effectiveness Research (CER) Core Leader, Colorado Health Outcomes and
the Children’s Outcomes Research Programs, School of Medicine
2006-2010 Senior Methodologist, Children’s Outcomes Research (COR) Program, School of Medicine
PROFESSIONAL POSITIONS
SCIENTIFIC CONSULTING
2015 Operationalizing pharmaceutical risk management and risk communication planning into
the drug development processes. Amgen, Inc.
2013 Colorado All-Payer Claims Database: data validity and feasibility assessment for
outcomes research. Janssen Scientific Affairs, LLC.
2013 Mock FDA Review Panel, Rx-to-OTC switch candidate. Merck & Co., Inc.
2013 Dextromethorphan Blue Ribbon Panel to review educational efforts to curb abuse among
adolescents. Consumer Healthcare Products Association.
2002-2005 Health Care New Business Development, Pharmaceutical and Wellness Market Research
Services, Information Resources, Inc., Chicago, IL.
U.S. FOOD AND DRUG ADMINISTRATION, ROCKVILLE, MD
2002-2003 Student research, Office of Drug Safety, Project: Effectiveness of risk management plans:
a case study of pemoline using pharmacy claims data. Advisor: Judy Staffa, RPh PhD.
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THE PROCTER & GAMBLE COMPANY, CINCINNATI, OH
2000-2002 Section Head, Global Phase III Project Leader, Cardiovascular New Drug Development,
Pharmaceutical Division
2000-2002 Section Head, Global Risk Management Team Leader, Cardiovascular New Drug
Development, Pharmaceutical Division
1997-2000 Section Head, Global Phase IIIb/IV Project Leader, Cardiac Technical Brand Manager,
Pharmaceutical Division
1996-1997 Section Head, U.S. Launch Team Leader for Helidac® (tetracycline, metronidazole,
bismuth-subsalicylate), North America Product Development, Pharmaceutical Division
1994-1997 Section Head, Technical Brand Manager, Asacol® (mesalamine) and Macrobid®
(nitrofurantoin monohydrate/macrocrystals), North America Product Development,
Pharmaceutical Division
1993-1994 Senior Scientist, Global Products Research Team Leader for Over-the Counter Cholesterol-
Lowering Drugs, Product Development, U.S. Healthcare Division
1992-1993 Senior Scientist, National Product Launch Team Leader, Metamucil® Sunrise Smooth
Sugar-Free Regular Flavor, Product Development, U.S. Healthcare Division
1988-1992 Scientist, Professional Oral Care Products, Product Development, U.S. Healthcare Division
MONSANTO CHEMICAL COMPANY, ST. LOUIS, MO
1987 Research Intern, Mammalian cell culture and cardiovascular pharmaceutical research
1986 Market Research Interviewer, Agriculture Products
HONORS AND AWARDS
ACADEMIC
2006 Delta Omega Honorary Society in Public Health (Alpha Chapter), Bloomberg School of
Public Health, The Johns Hopkins University
2004 Campaign for Epidemiology Award, Bloomberg School of Public Health, The Johns
Hopkins University
2003 Master of Public Health Capstone Award for Outstanding Achievement, Johns Hopkins,
Bloomberg School of Public Health
1988 Helen B. Schleman Award for Women, top academic female graduate, Purdue University
1988 AWS Very Important Woman Award, top graduating female leader, Purdue University
1988 School of Science Outstanding Senior, Department of Biology, Purdue University
1987 Mortar Board Honor Society for achievements in scholarship, leadership, and service,
Purdue University
1987 Phi Beta Kappa Society, Purdue University
1987 American Chemical Society Award for Outstanding Junior in Analytical Chemistry,
Purdue University
1984-1985 School of Science Research Scholarship, Purdue University
1984 National Presidential Scholar Finalist and National Merit Scholar
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SCIENTIFIC
2017 Mentored Student: RK Johnson. Winner of the Spotlight Poster Session: Benefit Risk
Assessment, Communication and Evaluation (BRACE) at the 32nd International
Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE),
Montreal, Canada, August 25-28, 2017.
2017 Mentored Student: KE Lind. Best Student Poster Finalist, at the AcademyHealth 2017
Annual Research Meeting, New Orleans, LA, June 25-27, 2017.
2015 “Best Poster”, Spotlight Poster Session “Benefit Risk Assessment, Communication and
Evaluation (BRACE)” at the 31st International Conference on Pharmacoepidemiology &
Therapeutic Risk Management (ICPE), Boston, MA. August 22-26, 2015.
2013 Outstanding Reviewer Recognition for 2013, Pharmacoepidemiology and Drug Safety
2011 Outstanding Reviewer Recognition for 2010, Pharmacoepidemiology and Drug Safety
2010 Outstanding Reviewer Recognition for 2009, Pharmacoepidemiology and Drug Safety
2010 Top 100 poster showcased in the President’s Poster Session and Reception at the 70th
Scientific Sessions of the American Diabetes Association, Orlando, FL June 25-29, 2010.
2010 Featured poster in “Pediatrics – Type 1 Diabetes – Care and Outcomes” at the 70th
Scientific Sessions of the American Diabetes Association, Orlando, FL June 25-29, 2010.
2008 Best research poster presented at the 2008 NCDEU (New Clinical Drug Evaluation Unit)
Meeting. CME Institute, Physicians Postgraduate Press, Inc., The Journal of Clinical
Psychiatry (October 2008)
2005 Best Podium Presentation, First Western Pharmacoeconomics Conference, Salt Lake City, UT
2004 Poster Finalist, 9th Annual Meeting of the International Society for Pharmacoeconomic and
Outcomes Research, Washington, D.C.
PHARMACEUTICAL INDUSTRY
1996 Asacol™ (mesalamine) Product Brand Team, Health Care Sector Outstanding
Achievement Award, The Procter & Gamble Company
1994 Team of the Year, Sunrise Smooth Metamucil Sugar-Free Regular Flavor National
Launch, U.S. Health Care Division, The Procter & Gamble Company.
PROFESSIONAL AFFILIATIONS
PROFESSIONAL SOCIETIES
2005- Member, International Society for Pharmacoepidemiology
Founding member of the Benefit-Risk Assessment, Communication and Evaluation
(BRACE) Special Interest Group (established 2012)
2007-2012 Member, American Diabetes Association
2005-2008 Member, International Society for Pharmacoeconomics and Outcomes Research
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PROFESSIONAL SERVICE AND COMMITTEES
INTERNATIONAL
2017 Moderator, Podium/Oral Session, “The "ACE" of BRACE”, 33rd International
Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE 2017),
Montreal, Canada. August 26-30, 2017.
2006-2007 Co-Chair, Policy Advocacy Working Group, Retrospective Database Special Interest
Group of the International Society for Pharmacoeconomics and Outcomes Research
2005-2006 Member, Policy Advocacy Working Group, Retrospective Database Special Interest
NATIONAL
2017 Expert Panel, "Addressing Barriers to Wide-scale Adoption of IPS Supported
Employment" Substance Abuse and Mental Health Services Administration’s
(SAMHSA’s) Center for Mental Health Services (CMHS). Rockville, MD. August 8, 2017.
2016 Discussant, “Policy Topics: Prescription Drugs, De-Implementation, and Military
Behavioral Health” 9th Annual Conference on the Science of Dissemination and
Implementation, Washington, D.C., December 14-15, 2016.
2015-present Colorado School of Public Health representative, Public Health Practice Section,
Association of Schools and Programs in Public Health
2015 Planning Committee and Moderator, Patient Engagement in Benefit-Risk Assessment
throughout the Life Cycle of Medical Product. Sponsored by the Drug Information
Association (DIA) and the Patient-Centered Outcomes Research Institute (PCORI).
Rockville, MD, September 17-18, 2015.
See: http://www.pcori.org/research-results/2015/patient-engagement-benefit-risk-
assessment-throughout-life-cycle-medical
2014 Member, Conjoint Committee on Continuing Education Long-Acting Opioid Analgesics
REMS Meeting, Accreditation Council for Continuing Medical Education Office,
Chicago, IL, February 24, 2014.
2014-2018 Standing member and Chair since 2017, FDA Pulmonary-Allergy Drugs Advisory
Committee, Center for Drug Evaluation and Research (see CV Appendix A)
2013-present Invited voting member, drug safety and risk management expertise, various FDA
Advisory Committees, Center for Drug Evaluation and Research (see CV Appendix A)
2011 Work Group presentation, Morrato EH, Meissner P, Concannon TW, Tobin J, Shah N.
“Key Informant Interviews: CER Dissemination and Implementation among CTSA
Institutions (preliminary findings)”. CER Collaboration, Information Dissemination,
Implementation Work Group, Presented at the Annual Comparative Effectiveness
Research Key Function Committee Meeting, October 11, 2011. Rockville, MD.
2010-2013 Comparative Effectiveness Research (CER) Key Function Committee, National Center
for Research Resources (NCRR) of NIH and the National Clinical and Translational
Science Award (CTSA) Consortium
2010-2011 Organizing Committee, Conference on Adipogenic and Metabolic Effects of
Antipsychotic Drugs (NIMH/NIDDK R13MH086166)
2009-2013 Standing Member, FDA Drug Safety and Risk Management Advisory Committee, Center
for Drug Evaluation and Research (see Appendix A)
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2008 Consultant, FDA Risk Communication Advisory Committee, “Research Regarding
Direct to Consumer Advertising of Prescription Drugs” (May 15-16, 2008)
2006-2009 Contributor, American Psychiatric Association (APA) Council on Research Workgroup
on Antipsychotics and Metabolic Risk. Newcomer JW, Blonde L, Ader M, Beaser R,
Marder S, Nemeroff C.
UNIVERSITY OF COLORADO ANSCHUTZ MEDICAL CAMPUS
2016-present Aurora Community Campus Partnership Steering Committee (see: http://com-cam.org/)
2016 Consultant, National Academy of State Health Policy (NASHP) Learning Collaborative
From Engagement to Evidence: Using PCOR and CER to Inform State Policymaking in
collaboration with the Colorado Department of Public Health and Environment, Office of
Behavioral Health, and Health Care Policy& Financing
2015-present Colorado Public Health Improvement Steering Committee (PHISC) representing the
Colorado School of Public Health
2008-2011 Member, Pediatric Scientific and Advisory Review Committee of the Colorado Clinical
Translational Research Center (CTRC) of the Colorado Clinical Translational Sciences
Institute (CCTSI)
2009-2010 Member, Sub-committee on Outcomes and Community Research, Development of
Children’s Hospital Colorado Strategic Research Plan, School of Medicine
2009 Chair, Faculty Search Committee, Director of the Qualitative Methods Core, Colorado
Health Outcomes Program, School of Medicine
COLORADO SCHOOL OF PUBLIC HEALTH
2015 Member, Faculty Search Committee, Associate Dean for Finance and Administration,
Colorado School of Public Health
2014-2015 Department representative, Education and Curriculum Committee
2013-2015 Faculty-member-at-large, Executive Council
2012, 15-16 Member, Departmental Appointments, Promotions, and Tenure Committee (DAPTCO)
2012-2014 Chair, Faculty Senate Finance Committee
2011-2012 Member, Faculty Search Committee, Associate Professor in Oral Health Epidemiology,
Department of Epidemiology
2010 Member, Founding Steering Committee for the Doctor of Public Health Program
2009-2012 Faculty Senator, Health Systems, Management and Policy Department
2009-2011 Member, Faculty Search Committee, Assistant/Associate Professor in Health Services
Research, Department of Health Systems, Management & Policy
2007 Reviewer, Doctorate of Public Health program proposal. Colorado School of Public
Health Initiative, University of Colorado at Denver and Health Sciences
OTHER SERVICE
2007-2008 Co-chair, Bergen Valley and Bergen Meadow Elementary School Science Fair,
Evergreen, CO
2004 Student representative to faculty, Doctorate of Public Health Program Executive
Committee, Johns Hopkins Bloomberg School of Public Health
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1998-1999 Member, Committee to develop the Pharmaceuticals Division Technical Brand Training
Manual on Best Practices. The Procter & Gamble Company.
1986-1988 President, School of Science Student Council, Purdue University
BOARD CERTIFICATION
2008 Board Certification in Public Health (Inaugural Class), National Board of Public Health
Examiners (Recertified 2012, 2015, 2017)
REVIEW, REFEREE, and EDITORIAL ACTIVITIES
GRANT REVIEW COMMITTEES AND STUDY SECTIONS
Standing Study Section, Permanent Member
2018 Invited to serve on the HSQR (Healthcare Patient Safety and Quality Improvement
Research) study section, Agency for Healthcare Research and Quality (AHRQ), pending
completion of FDA Advisory Committee service. AHRQ appointment process underway.
Invited Reviewer
2017 Special Emphasis Panel/Scientific Review Group 2017/10 HSQR SRO1 1, Healthcare
Patient Safety and Quality Improvement Research, Agency for Healthcare Research and
Quality (AHRQ), June 22-23, 2017.
Special Emphasis Panel ZMH1 ERB-K 05 M, Mental Health Services Research, National
Institute of Mental Health, April 7, 2017.
Special Emphasis Panel ZMH1 ERB-B (06) S, Fellowships and Dissertation Grants,
National Institute of Mental Health, March 1, 2017.
2016 Special Emphasis Panel ZMH1 ERB-K (01), Clinical Trials to Test the Effectiveness of
Treatment, Preventive, and Services Interventions (RFA-MH-15-320 and RFA-MH-15-
325), National Institute of Mental Health, November 30, 2016.
External Advisory Committee for the Merck Foundation’s Initiative: The Alliance to
Advance Patient-Centered Cancer Care. October 28, 2016.
Mental Health Services Research (SERV) Committee, National Institute of Mental
Health, June 2, 2016.
Special Emphasis Panel ZMH1 ERB-K (04), Clinical Trials to Test the Effectiveness of
Treatment, Preventive, and Services Interventions (RFA-MH-15-320 and RFA-MH-15-
325). National Institute of Mental Health, March 4, 2016.
2015 Special Emphasis Panel ZMH1 ERB-K (09), Fellowship and Dissertation Awards. National
Institute of Mental Health, July 14, 2015.
2014 Special Emphasis Panel, ZMH1 ZMH1 ERB-K (04), Mental Health Services, National
Institute of Mental Health, November 17, 2014.
Special Emphasis Panel, ZMH1 ZMH1 ERB-K (02) Mental Health Services. National
Institute of Mental Health, November 4, 2014.
Mental Health Services Research Committee (SERV), National Institute of Mental
Health. June 11, 2014.
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Special Emphasis Panel, ZMH1 ERB-I (03), Improving Health and Reducing Premature
Mortality in People with Severe Mental Illness (RFA-MH-14-060). National Institute of
Mental Health, March 5, 2014.
2013 Cycle III Merit Review, Communication and Dissemination. Patient Centered Outcomes
Research Institute (PCORI), July 18-19, 2013.
2012 Cycle I Merit Review, Assessment of Prevention, Diagnosis, and Treatment Options.
Patient Centered Outcomes Research Institute. October 2012.
Invited reviewer, Special Emphasis Panel ZHS1 HSR-X (03), Dissemination by Health
Professionals Associations. Agency for Healthcare Research and Quality, June 21, 2012.
2009 Special Emphasis Panel, 2009 ZRG1 HDM-P (58), Challenge Grants in Health and
Science Research. National Institutes of Health, July 20, 2009.
EDITORIAL REVIEW FOR BOOK PUBLISHERS
2016 Book prospectus: In the Margins: Health Behaviors and System Distrust among the
Socioeconomically Disadvantaged, Routledge publishers, member of the Taylor &
Francis Group, London.
MANUSCRIPT REVIEW FOR SCIENTIFIC JOURNALS
2017 Medical Care (2), BMJ Quality & Safety, Pediatrics, Drug Safety (2)
2016 Health Affairs, Pediatrics, Psychiatric Services, Medical Care, Therapeutic Innovation &
Regulatory Science (2), Journal of Clinical Psychiatry
2015 JAMA Internal Medicine, Journal of Clinical Psychiatry (2), BMC Psychiatry.
2014 Medical Care (2), Journal of General Internal Medicine, Pediatrics, New England Journal
of Medicine (2), Psychiatric Services, BMC Psychiatry, General Hospital Psychiatry
2013 JAMA Pediatrics, Medical Care, Pediatrics, Journal of General Internal Medicine,
Psychiatric Services, Pharmacoepidemiology & Drug Safety, General Hospital Psychiatry
2012 Value in Health, Psychiatric Services (2), American Journal of Managed Care (3),
BioMed Central Health Services Research, Pharmacy and Therapeutics Journal (2), Journal of Child and Adolescent Psychopharmacology (2), General Hospital Psychiatry,
2011 Archives of General Psychiatry, Medical Care, The Milbank Quarterly, American Journal
of Managed Care (2), Nature Reviews in Endocrinology, BioMed Central Public Health,
Journal of Psychopharmacology, Journal of Child and Adolescent Psychopharmacology,
Irish Journal of Psychological Medicine
2010 Pharmacoepidemiology and Drug Safety, Value in Health (2), Diabetologia, European
Journal of Cardiovascular Prevention and Rehabilitation, BioMed Central Health
Services Research (2), Journal of Psychopharmacology, Journal of Clinical
Psychopharmacology, Clinical Schizophrenia and Related Psychoses, Progress in Neuro-
Psychopharmacology & Biological Psychiatry, General Hospital Psychiatry
2009 Archives of Internal Medicine, Pharmacoepidemiology & Drug Safety, American Journal
of Managed Care, Diabetologia, Journal of Child and Adolescent Psychopharmacology,
Neuro-Psychopharmacology and Biological Psychiatry, Social Psychiatry and Psychiatric
Epidemiology, BioMed Central Psychiatry, Journal of Diabetes and its Complications
2008 Journal of Clinical Psychopharmacology, Health Policy, American Journal of Psychiatry,
Journal of Health Services Research and Policy
2006 Schizophrenia Bulletin
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REVIEWER FOR PROFESSIONAL SOCIETIES AND SCIENTIFIC CONFERENCES
2007-9, 11-12, Scientific abstracts, International Conference on Pharmacoepidemiology and Therapeutic
15-17 Risk Management
2008 Symposium abstracts, “Contributed Health Decisions Case Study”, International Society for
Pharmacoeconomics and Outcomes Research
INVITED LECTURES, PRESENTATIONS, WORKSHOPS
INTERNATIONAL
1. Speaker, “Pragmatic Approaches from Implementation Science to Better Risk Management
Programs”, sponsored by the Benefit-Risk Assessment, Communication and Evaluation
(BRACE) Special Interest Group, International Society for Pharmacoepidemiology Educational
Webinar Series. October 10, 2017.
2. Speaker and Panelist, “Pragmatic Design Considerations: The PRECIS-2 Framework” in Session:
“Are Pragmatic Clinical Trials Ready for Prime Time?”, Duke Industry Statistics Symposium
2017. September 6-8, 2017, Durham, NC. [International sponsorship: Amgen, Boehringer-
Ingelheim, Janssen, Parexel, PPD, Quintiles and SAS and pharmaceutical industry participation]
3. Speaker, “Pragmatic Approaches from Implementation Science to Better Risk Management
Programs”, sponsored by the Benefit-Risk Assessment, Communication and Evaluation
(BRACE) Special Interest Group, International Society for Pharmacoepidemiology Educational
Webinar Series. October 20, 2016.
4. Speaker, “Introduction to Pragmatic Trials and the PRECIS-2 Framework”, 7th International
Dermato-Epidemiology Association (IDEA) Congress and 2nd Keratinocyte Carcinoma
Consortium (KeraCon) Meeting. Aurora, CO. September 28-30, 2016.
5. Speaker and Panelist, Mind the Gaps - and Address Them! The science of designing,
implementing and evaluating benefit-risk communication for medicinal products. Drug
Information Association 2016 52nd Annual Meeting, Philadelphia, PA, June 26-30, 2016. [DIA
meeting is premier global forum convening health care product development professionals]
6. Speaker, “Practical Approaches to Designing, Implementing, and Evaluating REMS and Risk
Minimization Programs” Amgen Inc., Thousand Oaks, CA, April 13, 2015
7. Symposium Moderator, Benefit-Risk Assessment, Communication and Evaluation (BRACE):
Embrace the challenges and opportunities. Sponsored by the Benefit-Risk Assessment,
Communication and Evaluation (BRACE) Special Interest Group. 29th International Conference on
Pharmacoepidemiology and Therapeutic Risk Management, Montreal, Canada, August 25-28, 2013.
8. Speaker, “Methodologic issues in epidemiologic and pharmacovigilance studies of APD
metabolic effects”, Conference on Adipogenic and Metabolic Effects of Antipsychotic Drugs with
funding in part from the National Institute of Mental Health and the National Institute of Diabetes
and Digestive and Kidney Disease (R13MH086166), Newark, NJ, July 11-12, 2011.
9. Speaker and Panelist, Mol P, Bahri P, Avorn J, Benkimoun P, Aria A, Morrato EH, Dal Pan G,
Haaijer-Ruskamp F, Straus S. “Intended and Unintended Consequences: The case example of
SSRI suicidality risk communication” in the Symposium “Regulatory Risk Communication: Are
We Getting Ahead?" 26th International Conference on Pharmacoepidemiology & Therapeutic
Risk Management, Brighton, UK, August 19-22, 2010.
10. Speaker, “Comparative Effectiveness Research Funding in the United States” Cochrane Skin
Group Annual Meeting, University of Colorado Denver, Aurora, CO, October 16-17, 2010.
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11. Speaker, “Utilization of Retrospective Databases to Inform Evidence Based Drug Policy Making”
International Society for Pharmacoeconomics and Outcomes Research 11th Annual International
Meeting. Philadelphia, PA, May 2006.
12. Speaker, “HELIDAC Therapy: A Newly FDA-Cleared Therapy Designed for Compliance,”
International Business Communications Meeting on H. pylori, January 1997.
NATIONAL
1. Grand Rounds, “Advancing Dissemination and Implementation Science at the Colorado Clinical
and Translational Science Institute”, Cincinnati Clinical and Translational Sciences Institute.
Cincinnati, OH, December 15, 2017.
2. Grand Rounds, “The Professional Practice Gap in Healthcare Dissemination and Implementation:
Applications for Mental Health”, The Zucker Hillside Hospital, A division of North Shore, Long
Island Jewish Health System, Department of Psychiatry, Glen Oaks, NY. April 26, 2017.
3. Speaker, “Dissemination and Uptake of CER” in the conference Comparative Effectiveness and
Patient-Centered Outcomes Research: Enhancing Uptake and Use by Patients, Clinicians and
Payers, sponsored by the Academy of Managed Care Pharmacy and the PhRMA Foundation,
Washington, D.C., January 26-27, 2017
4. Webinar, “An Introduction to Implementation Science”, Palliative Care Research Cooperative
Group Webinar, Denver, CO, July 13, 2016.
5. Speaker, “An Introduction to Implementation Science”, Palliative Care Research Cooperative
Group Investigator Meeting, Denver, CO, March 24, 2016.
6. Speaker, “Metabolic Screening: Prioritizing Implementation Strategies for Mental Health”
(findings from R21 MH097045). SMINET Learning Consortium: Applying Evidence to Improve
Care and Outcomes in Severe Mental Illness AHRQ 1R18HS023258, February 22, 2016.
7. Symposium, Morrato EH, Sheridan S, Miller T. “Implementation of Appropriate Use of Clinical
Preventive Services: Setting a National Research Agenda”. Agency for Healthcare Research and
Quality Annual Research Meeting with Academy Health, Arlington, VA. October 5, 2015.
8. Speaker, Public Workshop on Risk Evaluation and Mitigation Strategies: Understanding and
Evaluating Their Impact on the Health Care Delivery System and Patient Access, Silver Spring,
MD, October 5-6, 2015, Docket No. FDA-2013–N–0502
9. Speaker, FDA meeting with the Conjoint Committee on Continuing Education Long-Acting
Opioid Analgesics REMS Meeting, Accreditation Council for Continuing Medical Education
Office, Washington, D.C., July 22, 2015.
10. Speaker, “Metabolic Screening: Prioritizing Implementation Strategies for Mental Health
Patients”. Missouri CMHC Healthcare Home Operations Meeting. August 18, 2014.
11. CME Symposium, Miller T, Harris R, Baker D, and Morrato EH. “The Importance of
Population Thinking in Prevention” Preventive Medicine 2014. New Orleans, LA, February 19-
22, 2014.
12. Speaker, “Marketing: What Can We Learn to Improve Health Dissemination and
Implementation?” University of Washington Centers for Comparative & Health Systems
Effectiveness, CHASE Alliance. Seattle, WA, March 11, 2013.
13. CME Lecturer, “Metabolic Monitoring among Persons with Mental Illnesses: Lessons Learned,
Insights for Future Direction”, Physical Health and Behavioral Health Integration: Preventing
Diabetes among People with Mental Illness. APS Healthcare and Maine Department of Health
and Human Services Data Forum and the Center for Health Services Research on
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Pharmacotherapy, Chronic Disease Management, and Outcomes and the Center for Education
and Research on Mental Health Therapeutics, Rutgers University. January 31, 2013.
14. Panelist, Expert Workshop on Strengthening Risk Evaluation and Mitigation Strategies (REMS)
through Systematic Analysis, Standardized Design, and Evidence-Based Assessment. The
Engelberg Center for Health Care Reform, Brookings Institution, Washington, DC, September
25, 2013.
15. Panelist, Expert Workshop on the Safety and Long-Term Efficacy of Extended-Release and
Long-Acting Opioid Analgesics, co-hosted by the FDA’s Center for Drug Evaluation and
Research and the Clinical Trials Transformation Initiative (CTTI), Silver Spring, MD, August 12-
13, 2013.
16. Contributor, principles for good comparative effectiveness research, as published in: The GRACE
Checklist for Rating the Quality of Observational Studies of Comparative Effectiveness: A Tale
of Hope and Caution. Dreyer NA, Velentgas P, Westrich K, Dubois R. J Manag Care Pharm.
2014; 20(3):301-8.
17. Panelist, Public Workshop on “Risk Evaluation and Mitigation Strategy (REMS) Assessments:
Social Science Methodologies to Assess Goals Related to Knowledge” Public Workshop, Silver
Spring, MD, June 7, 2012, Docket No. FDA-2012-N-0408
18. Speaker, “Mixed methods in health services research to understand real-world acceptance of
safety recommendations for pscyhopharmacologic treatments” in the symposium on “Balancing
Benefits, Risks and Cost for New Treatments in Vulnerable Populations: Lessons from Child
Psychiatry on the Need for a New Standard of Diverse Methodologies”. Co-Chairs: Correll C
and Newcomer JW. Panelists: Arango C, Nicol G, Morrato E, Kymes S. 51st American College
of Neuropsychopharmacology (ACNP) Annual Meeting in Hollywood, FL, December 2-6, 2012.
19. CME lecturer, “Metabolic Monitoring: Current Knowledge, Future Directions”, Integrating
Behavioral Health and Primary Care: Antipsychotic Medications and Cardiometabolic
Monitoring. CalOptima, Beacon Health Strategies, Orange County Health Care Agency, and the
Center for Health Services Research on Pharmacotherapy, Chronic Disease Management, and
Outcomes and the Center for Education and Research on Mental Health Therapeutics, Rutgers
University. Orange County, CA, June 13, 2012.
20. Speaker, “Dissemination and Implementation of CER Evidence: What Can We Learn from the
Consumer Products Industry?” DARTNet Comparative Effectiveness Research (CER) Learning
Group, May 24, 2012.
21. Speaker, “Drug Safety Policy in the U.S.: Current Direction and Public Health Considerations”
Mental Health Concentration Seminar, Rollins School of Public Health, Emory University,
January 25, 2012.
22. Speaker,“Diffusion of Drug Warnings Among Physicians: Getting the most out of electronic
patient data” U.S. Food and Drug Administration Center for Drug Evaluation and Research,
Office of Surveillance and Epidemiology Seminar Series, Silver Spring, MD, June 23, 2011.
23. Think Tank Leader, Morrato EH, Marosits M, Dearing JW. Social Network Science and Social
Media Tools, 4th Annual National Institutes of Health Conference on the Science of
Dissemination and Implementation, Bethesda, MD, March 21-22, 2011.
24. Panel Discussant, Eggleston M, Frasso R, Harris HS, Masterson EA, Morrato EH, Navarro
Silvera S. “Everything you ever wanted to know about being Certified in Public Health, but didn't
know who to ask" 138th American Public Health Association Annual Meeting, Denver, CO
November 6-10, 2010.
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25. Plenary Panel, Morrato EH, “Synthesis, generation and translation of comparative effectiveness
evidence and patient-centered outcomes research” in “Health Care Reform: How will we measure
progress?” The Culture of Data 2010: Health Reform and Health Disparities: Where from here?,
U.S. Department of Health and Human Services U.S. Public Health Service Region VIII, The
Arvada Center for the Performing Arts, Arvada, CO, October 8, 2010.
26. Speaker, Morrato EH, “Diffusion of Drug Warnings The Case Example of Antipsychotics and
Metabolic Risk”, Rocky Mountain Poison Control and Drug Center, Denver Health Association,
Denver, CO, September 2, 2010.
27. Symposium Speaker, Newcomer JW, Haupt D, Morrato EH, Parks J. “Why psychiatry is a
branch of medicine: an update on screening and monitoring cardiometabolic risk during mental
health treatment.” 60th Institute on Psychiatric Services. Chicago, IL, October 2-5, 2008.
28. Visiting Professor, Morrato EH, “Atypical antipsychotic drugs and metabolic testing: Assessing
response to the FDA warnings”, U.S. Food and Drug Administration Center for Drug Evaluation
and Research (CDER) Visiting Professor Lecture Series (VPLS), Rockville, MD, July 2008.
29. CME Poster Presentation, Morrato EH, Newcomer JW, Kamat S, Baser O, Harnett J, Cuffel B.
Impact of the atypical antipsychotic FDA Warning on risk of hyperglycemia and diabetes and
metabolic monitoring practices. NCDEU CME Poster Session 2008. Best research posters
presented at the 2008 NCDEU (New Clinical Drug Evaluation Unit) Meeting. CME Institute,
Physicians Postgraduate Press, Inc., The Journal of Clinical Psychiatry, October 2008.
30. CME Lecturer, Morrato EH, “Prevalence of baseline serum glucose and lipid testing in users of
second-generation antipsychotic drugs: A retrospective, population based study of Medicaid
claims data”, Schizophrenia CME E-Journal Club, Editor: John M. Kane, Albert Einstein College
of Medicine, May 2008.
31. CME Lecturer, Morrato EH, “Physical Activity in U.S. Adults with Diabetes and At Risk For
Developing Diabetes”, Primary Care Edition of the Cardiometabolic E-Journal Club, Editor:
Jorge Plutzky, Brigham and Women's Hospital, Harvard Medical School, January 2008.
32. Speaker, Morrato EH, “Drug safety: Can it be managed?” Graduate Summer Institute of
Epidemiology and Biostatistics Seminar Series, The Johns Hopkins Bloomberg School of Public
Health, Baltimore, MD, June 2007.
33. Speaker, Morrato EH, “Epidemiology of pediatric surgery” Pediatric National Surgical Quality
Improvement Program (NSQIP): protocol development meeting, American College of Surgeons,
Chicago, IL, April 2007.
34. Speaker, “Impact of Nefazodone (Serzone®) Hepatic Risk Minimization Recommendations: A
Case Study Evaluation of an FDA Boxed Warning”, Office of Drug Safety Research Seminar,
U.S. Food and Drug Administration, Rockville, MD, June 2006.
REGIONAL AND LOCAL
1. Speaker, “Best Practices on Open Innovation”, Silicon Flatirons Roundtable: Building a Great
Health Care Innovation Ecosystem, Denver, CO, June 2017.
2. Speaker, Morrato EH, Thomas D. “Using Big Data for Dissemination and Implementation
Science Research: Linking Survey, Claims, and Geospatial Data Analyses to Study Diabetes
Screening Implementation in Missouri Medicaid Patients with Mental Illness”, Insights and
Innovation in Improving Health Seminar Series, Adult and Child Consortium for Health
Outcomes Research and Delivery Science, University of Colorado Anschutz Medical Campus,
Aurora, CO, April 2017
3. Speaker, “FDA, Prescription Drugs and You”, Tuesday Morning Class, Denver, CO, December 2015.
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4. Speaker, “Pulling Back the Curtain: the FDA, Prescription Drugs, and You”, The University of
Colorado Boulder Directors Club, Vail, CO, June 2015.
5. Speaker, “Dissemination and Implementation Science: Resources and Opportunities”,
Department of Medicine Faculty Conference on Research and Innovation, University of Colorado
Anschutz Medical Campus, January 2014.
6. Workshop Faculty, Rabin B, Morrato EH. “Dissemination and Implementation Science and
Practice 101” Skill-Building Session, Public Health in the Rockies Conference, Breckenridge,
CO, September 2013.
7. Speaker, “The Field of Healthcare Marketing: Implications for Dissemination and
Implementation Practice”, Insights and Innovation in Improving Health Seminar Series, Center
for Research in Implementation Science and Prevention (CRISP), University of Colorado,
Anschutz Medical Campus (January 2013)
8. Speaker, “Dissemination and Implementation”, Qualitative Methods Showcase, University of
Colorado, Anschutz Medical Campus (October 2012)
9. Speaker, “Questions concerning periodontal disease prevalence in adolescents with diabetes:
clinical and health education implications”, Colorado Health Outcomes Research Seminar,
University of Colorado Denver, Aurora, CO (November 2010)
10. Speaker, Barnard J, Morrato EH “Caregivers’ and Relatives’ Expectations for Spinal) Surgery
(CARES) Study”, Colorado Health Outcomes Research Seminar, University of Colorado Denver,
Aurora, CO (February 2009).
11. Speaker, “Influences of Individual and Geographic Factors on Drug Safety Practices:
Applications for Antipsychotics and Diabetes Risk”, Colorado Health Outcomes Methods and
Applications Seminar, University of Colorado Denver, Aurora, CO (January 2009).
12. Speaker, Benton K, Morrato EH “Epidemiology of Pediatric Surgery: Results from KID 2003”,
Colorado Health Outcomes Research Seminar, University of Colorado Denver, Aurora, CO
(April 2008)
13. Speaker, “Understanding Quality of Life issues for children undergoing spinal fusion surgery for
scoliosis: the special case of children with neuromuscular disorders”, Qualitative Methods
Research Forum, University of Colorado Denver, Denver, CO (November 2007)
14. Speaker, “PHIS and KID: Secondary data sources for pediatric hospitalization outcomes”, Colorado
Health Outcomes Research Seminar, University of Colorado at Denver and Health Sciences Center,
Aurora, CO (April 2007)
15. Speaker, “Specificity and sensitivity: Implications for clinical decision making and research” Rehab
Science and Engineering Consortium (RSEC) Seminar, University of Colorado at Denver and Health
Sciences Center, Denver, CO (April 2007)
16. Speaker, “Evaluating Physician Adoption of FDA Drug Warnings: How do we get the most out of
administrative claims data?” Department of Preventive Medicine Research Seminar, University of
Colorado at Denver and Health Sciences Center, Denver, CO (January 2007)
17. Guest Speaker, “How I use statistics in my job”, Bergen Valley Elementary School, Evergreen, CO
18. Speaker, “Lessons Learned from Consumer Product Research” Qualitative Research Methods
Forum, University of Colorado at Denver and Health Sciences Center, Aurora, CO (November 2006)
19. Speaker, “From MEPS to Medicaid: Outcomes Research Learning in Diabetes and Mental Health”
Fellowship Seminar, Department of Clinical Pharmacy Seminar Series, University of Colorado at
Denver and Health Sciences Center, Denver, CO (July 2006)
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20. Speaker, “Pharmaceutical Risk Management Evaluation”, Colorado Health Outcomes Methods and
Applications Seminar, University of Colorado at Denver and Health Sciences Center, Aurora, CO
(February 2006)
21. Guest Speaker, “Food nutrition and how to read and understand food labeling”. Bergen Valley
Elementary School, Evergreen, CO (Spring Semester, 2005 and 2006)
22. Speaker, “Ethical Issues in Drug Product Risk Assessment and Communication” Western Drug
Safety and Pharmacoepidemiology Conference. Napa, CA, October 2005.
23. Speaker, “Impact of Relabeling on Nefazodone (Serzone®) Prescribing: A Risk Minimization
Evaluation”, First Western Pharmacoeocnomics Conference. Salt Lake City, UT, March 2005.
TEACHING RECORD
AWARDS AND RECOGNITION
2013 Training the Next Generation of Leaders in Clinical Preventive Services: Profiles from
the AHRQ Research Centers for Excellence. November 2013. Agency for Healthcare
Research and Quality, Rockville, MD. http://www.ahrq.gov/professionals/prevention-
chronic-care/decision/research-centers/rce_profile_morrato.html
Also see: Achievements in Prevention: Training to Implement Clinical Preventive
Services at http://www.ahrq.gov/sites/default/files/wysiwyg/professionals/prevention-
chronic-care/decision/research-centers/training_professionals.pdf
2012 “Science Meets Writing: Health science instructors utilize Writing Center to develop student
skills” by Amy Vaerewyck. Spotlight Stories. University of Colorado Denver | Anschutz
Medical Campus. October 14, 2012.
http://www.ucdenver.edu/about/newsroom/spotlight/students/Pages/Public-Health-Writing.aspx
2012 President’s Excellence in Teaching Award, Colorado School of Public Health, University
of Colorado Anschutz Medical Campus, Aurora, CO
NATIONAL CURRICULA DEVELOPMENT AND EDUCATION
2017 Invited Adjunct Instructor, National Innovation-Corps (I-Corps™) Training Program,
National Science Foundation, Denver, CO, July 30 – September 15, 2017.
2017 Invited Participant, Training the Next Generation of Implementation Researchers for
Health Equity Workshop, Center for Translation Research and Implementation Science
(CTRIS), National Heart, Lung, and Blood Institute (NHLBI), National Institutes of
Health, Bethesda, MD, August 30-31, 2017.
2016-2017 Workshop Faculty, Pre-Conference Course: Introduction to Therapeutic Risk Management
33rd International Conference on Pharmacoepidemiology & Therapeutic Risk
Management (ICPE), Montreal Canada, August 26-29, 2017
32nd International Conference on Pharmacoepidemiology & Therapeutic Risk
Management (ICPE), Dublin, Ireland, August 25-28, 2016.
2015 Developed and Delivered Invited Workshop, “Introduction to Implementation Science”,
American Academy of Pediatrics, Chicago, IL, April 1, 2015.
2014 Invited Participant, Conference for Developing Curricula for Teaching Patient Centered
Comparative Effectiveness Research sponsored by the Agency for Healthcare Research
and Quality, the Patient Centered Outcomes Research Institute, Pew Charitable Trust, and
the PhRMA Foundation, Washington, D.C., January 28-29, 2014.
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2013 Item Writer, Epidemiology and Health Policy & Management, for Board Certification in
Public Health, National Board of Public Health Examiners
2011 Invited training module, annotated bibliography, and self-assessment questions on
“Pharmacovigilance and FDA Drug Safety Policy”, Chronic Illnesses, Pharmacotherapy
Self-Assessment Program, Seventh Edition, for Board Certification in Clinical Pharmacy,
American College of Clinical Pharmacy
2006 Developed and Delivered Invited Workshop, “Pharmaceutical RiskMAP Evaluation”,
Merck & Co., Inc.
GRADUATE CURRICULA DEVELOPMENT (Colorado School of Public Health)
2014-2015 Program Director, Certificate of Professional Achievement in Health Industry Analytics Pilot
Program, Colorado School of Public Health, CU South Denver
2009-2010 Steering Committee, Doctor of Public Health Program, Colorado School of Public Health
GRADUATE COURSES TAUGHT AND DEVELOPED (Colorado School of Public Health)
2015, 2016 Introduction to Health Systems, Management and Policy (HSMP 6601). University of
Colorado (70-80 students) and Colorado State University (35 students).
2015 Data-Driven Quality Improvement (HSMP 6643) (8-10 students)
2013 - 2014 Introduction to Health Policy Analysis and Communication (HSMP 6616). (20 students)
2011-2014 Health Policy (HSMP 6605) (20-30 students).
2011 Co-Instructor, GIS for Public Health Research and Practice (EHOH 6621). (20 students)
2011 - Independent Study: Health Systems, Management and Policy (HSMP 6840)
Kelsey Ford (MPH candidate, Community Behavioral Health), 2016
Project: Innovation-Corps Customer Discovery for a Pediatric mHealth Intervention
Erin Seedorf (DrPH candidate, Community and Behavioral Health), 2012
Project: Methods for Evaluating Local Policy Development and Implementation
Michele Shikomura (M.P.H. candidate, Epidemiology), 2011
Publishable paper: Health Care Reform: Impact to Service Providers and a Vulnerable
Population of Adults Living with HIV. An analysis of the Ryan White CARE Act in the
Part A Denver Transitional Grant Area
GUEST LECTURES TAUGHT AND DEVELOPED (University of Colorado Anschutz Medical Campus)
2015-2017 Clinical Reasoning and Decision Making (PRDO 7800, iPharmD® program). Topic:
Clinical Decision Making Process: Government, Law, and Industry. Skaggs School of
Pharmacy and Pharmaceutical Sciences (25 students)
2015 Evidence Based Medicine (MPAS 6701) Topic: comparative effectiveness research.
Child Health Associate / Physician Assistant Program. School of Medicine. (75 students)
2015, 2017 Pharmacoepidemiology (PHSC 7615 / EPID 7615) Topics: FDA Drug Approval, Risk
2014-2016 Clinical Reasoning and Decision Making (PHRD 6965). Topic: Decision Making: Drug
Warnings. Skaggs School of Pharmacy and Pharmaceutical Sciences (125-150 students)
2014, 2016 Dissemination and Implementation Research in Health (CLSC 7653). Topics: The Field of
Healthcare Marketing: Implications for Dissemination and Implementation Practice and
Health Policy Implementation. Clinical Science Graduate Program (8-10 students)
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2012 - 2013 GIS Application in Health Policy. GIS for Public Health Research and Practice (EHOH
6621). Colorado School of Public Health (25 students)
2012 Research Methods using Secondary Datasets (EPID 7605). Topic: Secondary Datasets
Used in Health Services Research. Colorado School of Public Health (10 students)
2011 Transition to Residency and Beyond (ICC 8004). Topic: FDA Drug Regulation. School
of Medicine (est. 125 students)
2010, 2011 Health Services Research in Public Health and Health Policy Research (HSMP 6670).
Topic: Comparative Effectiveness Research in the U.S. Colorado School of Public
Health (5-10 students)
2009, 2011 Communication and Management. Skaggs School of Pharmacy and Pharmaceutical
Sciences and Colorado School of Public Health (8-10 students)
2009 Applied Database Research (PHSC 7622). Topic: Analyzing Medicaid Data. Skaggs
School of Pharmacy and Pharmaceutical Sciences (5 students)
2008 Special Topics in Outcomes Research (PHSC 7570). Topic: FDA, Risk Evaluation and
Mitigation Strategies (REMS), and Future Direction for Drug Safety Policy. Skaggs
School of Pharmacy and Pharmaceutical Sciences (3 students)
2008 Research Methods (PHSC 7621). Topic: Medicaid Databases. Skaggs School of
Pharmacy and Pharmaceutical Sciences (5 students)
2007 Biostatistics (PHRD 4400). Topic: Study Designs in Clinical Research. Skaggs School
of Pharmacy and Pharmaceutical Sciences (est. 125 students)
2006-2008 Cost Effectiveness Analysis and Pharmacoeconomics (PHRD 5400). Topic: U.S. Drug
Advertising and Patient-Reported Outcomes. Skaggs School of Pharmacy and
Pharmaceutical Sciences (est. 125 students)
2005-2008 Health Care Systems (PRMD/HSMP 6603). Topic: Drug Development and the History
of FDA Regulation. School of Medicine (est. 40 students)
2005, 2006 Biostatistics (PHRD 4400). Topic: Categorical Data: Comparing Groups. Skaggs
School of Pharmacy and Pharmaceutical Sciences (est. 125 students)
2005 Biostatistics (PHRD 4400). Topic: Descriptive Statistics. Skaggs School of Pharmacy
and Pharmaceutical Sciences (125 students)
2004 Biostatistics (PHRD 4400). Topic: Hypothesis Testing and Power. Skaggs School of
Pharmacy and Pharmaceutical Sciences (125 students)
OTHER GUEST LECTURES TAUGHT AND DEVELOPED
2007 Pharmacoepidemiology (340.617.11). Topic: Drug Safety & Risk Management. Epidemiology
and Biostatistics Summer Institute, Johns Hopkins Bloomberg School of Public Health
1992-1995 Qualitative Methods Instructor, corporate training course: “PRISM 101, Understanding
consumers and communicating with them”, The Procter & Gamble Company
1992, 1994 Instructor, Health Care Division Diversity program, The Procter & Gamble Company.
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RESEARCH WORKSHOPS DIRECTED (University of Colorado Anschutz Medical Campus)
2015 “Introduction to Pragmatic Trials”, Center for Research in Implementation Science and
Prevention (100 participants)
2013 “Introduction to Dissemination and Implementation Science Workshop”, Center for
Research in Implementation Science and Prevention (75 participants)
SEMINAR SERIES DIRECTED AND DEVELOPED (University of Colorado Anschutz Medical Campus)
2013-2015 Insights and Innovation in Improving Health Seminar Series, Colorado Research on
Implementation Science Program
2006-2007 Outcomes Research Methodology Series, Department of Pediatric Surgery, Children’s
Hospital Colorado
TEACHING ASSISTANT
2003 Biostatistical Analysis Workshops I and II (140.613 and140.614). Winter Institute, Johns
Hopkins Bloomberg School of Public Health
ADVISING & MENTORING
K-Award Mentees
2015-2020 Beth McManus, PT, MPH, ScD (primary mentor)
Associate Professor, Department of Health Systems, Management and Policy, Colorado
School of Public Health, University of Colorado Anschutz Medical Campus
Comprehensive Opportunities in Rehabilitation Research Training (CORRT), NIH K12
HD055931, Washington University, St. Louis
Project: Understanding and Improving Early Intervention Therapy Access, Service Use,
and Outcomes
2017-2020 James A. Feinstein, MD, MPH (drug safety content mentor)
Assistant Professor, Department of Pediatrics, University of Colorado Anschutz Medical Campus
Colorado Clinical and Translational Science Institute KL2 (K12) Research Scholar
Program, NIH/NCATS Colorado CTSA Grant Number KL2 TR001080
NIH/NICHD Mentored Patient-Oriented Research Career Development Award, K23
HD091295 (Pending, Scored: 10)
Project: Enhancing Medication Safety in Children with Polypharmacy using Parent-
Reported Symptom Assessments
2010-2015 Ginger E. Nicol, MD (health services research mentor)
Assistant Professor, Department of Psychiatry, Washington University in St. Louis
National Institute of Mental Health Mentored Patient-Oriented Research Career
Development Award (K23MH092435)
Project: Measurement of Cardiometabolic Risk in Antipsychotic-Treated Children
T32 Mentees and Other Post-Doctoral Fellows
2016-2018 Demetria McNeal, PhD MBA (primary mentor)
Post-Doctoral Fellow in Dissemination Science in Health
Adult and Child Consortium for Health Outcomes Research and Delivery Science
University of Colorado Anschutz Medical Campus
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2016-2018 Nicole Amoyal Pensak, PhD (implementation scientist mentor)
Institutional NRSA (T32) Palliative Care and Aging Research Training
University of Colorado Anschutz Medical Campus
Project: A Randomized Controlled Trial of Mobilized Psychoeducation and Skills Based
Intervention (PEP-PAL) for Caregivers of Patients with Advanced Illness
2014-2016 Katherine Sauder, PhD (implementation science mentor)
National Institute for Diabetes and Digestive and Kidney Diseases, Nutrition Training
Grant (T32 DK07658-27) and Center for American Indian and Alaska Native Diabetes
Translational Research (CAIANDTR), P30 DK092923
University of Colorado Anschutz Medical Campus
Project: Reducing Risk Factors for Type 2 Diabetes in American Indian Youth: Tribal
Turning Point
2012-2014 Lauren Garfield, PhD (health services research mentor)
National Heart, Lung, and Blood Institute (T32 HL007456-28)
Washington University in St. Louis
Project: Metabolic Screening Rates in Adults and Youth Receiving Antipsychotic Medication
Doctoral Dissertation Committees, Colorado School of Public Health
2016- Kimberly Lind, MS (committee member)
Ph.D. in Health Services Research
2013-2017 Erin Seedorf, MPH (committee member)
Dr.P.H. in Community and Behavioral Health
Dissertation: Assessing the Effects of Policy Networks on Local Public Health Tobacco
Control Policy Networks Initiatives
2010-2016 KaraAnn Clouse, MSPH (mentor)
Ph.D. in Health Services Research
Dissertation: The Effect of Medical Home Legislation on Colorado’s Pediatric Practices
and Health Services Use in Children
Doctoral Dissertation Committee, Arnold School of Public Health, University of South Carolina
2012-2014 Georges Nahhas (committee member)
Ph.D. in Epidemiology
Arnold School of Public Health, University of South Carolina
Dissertation: Periodontal Disease and Obesity among Youth with Type 2 Diabetes Mellitus
Masters Thesis
2008 Valerie A. Orlando, RDH (reader)
Masters in Clinical Education
University of New South Wales
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RESEARCH RECORD: ACADEMIC
PI, SITE PI OR CENTER GRANT CORE LEADER
PENDING
Colorado Clinical and Translational Sciences Institute (CCTSI) 5/1/2018 – 4/30/2023
NIH / NCATS (PI: Sokol) Overall Impact Score : 13
Purpose: The Clinical and Translational Science Award supports Colorado’s institutional home for
research and training in clinical and translational sciences. This seeks continuation of the CCTSI.
Roles: PI, Optional Function: Partnering for Innovation, Value Optimization, and Accelerated
Translation (PIVOT) (15% effort)
Core Lead, Dissemination (20% effort)
ACTIVE
CTSA Accrual to Clinical Trials (ACT) 10/1/2016-5/31/2021
NIH / NCATS UL1 TR001857-S, Administrative Supplement (PI: Reis)
Purpose: This administrative supplement supports the national dissemination of an EHR-based
informatics solution to improve clinical trial cohort discovery and recruitment creating an ACT
research Network across 60+ academic medical research centers in the U.S.
Role: Site PI and Dissemination Lead (15% effort)
Amount: $10 MM (Total Costs 5 years)
Center for American Indian and Alaska Native Diabetes 8/1/16–7/31/2021
Translational Research (CAIANDTR) P30 DK092923, National Institute of Diabetes and Digestive and Kidney Diseases (PI: Manson)
Purpose: To develop strategies and processes for translational research within the context of American
Indian/Alaskan Native health disparities specific to the prevention and management of diabetes
Role: Core Lead, Dissemination (3% effort)
Amount: $5 million (Total Direct Costs 10 Years)
Patient Integrated Value and Organizational Transformation Center 3/1/2016-2/28/2021
University of Colorado Dean of Medicine Transformational Award (PIs: Ho/Kutner/Schilling/Kahn)
Purpose: To link research and clinical innovation to transform our health system and espouse the
principles of patient-centeredness, increased quality, and lower costs.
Role: Core Lead, Dissemination (10% effort, suspended when assumed Interim Dean appointment)
Amount: $20 MM (Total Costs 5 years)
I-Corps Train-the-Trainer Program 04/01/2017-3/31/2019
NIH / NCATS UL1TR001417-02S, Administrative Supplement (PI: Kimberly)
Purpose: This administrative supplement supports adaptation of the NSF (I-Corps™) program for
clinical and translational scientists and its dissemination across the CTSA consortium to
provide researchers the skills necessary for commercializing biomedical innovation.
Role: Site PI (5% effort)
Amount: $850,000 (Total Costs 2 years)
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State Tobacco Education and Prevention Partnership (STEPP) 5/1/2016-5/31/2018
Tobacco Training and Technical Assistance
16 FHLA 79830, Colorado Department of Public Health and Environment (PI: Morrato)
Purpose: To "provide funding for community-based and statewide tobacco education programs designed
to reduce initiation of tobacco use by children and youth, promote cessation of tobacco use
among youth and adults, and reduce exposure to secondhand smoke”.
Role: PI (5% effort)
Amount: $824,947 (annual direct costs)
Colorado Clinical and Translational Sciences Institute (CCTSI) UL1TR001082, TL1TR001081, KL2TR001080, NIH / NCATS (PI: Sokol) 10/1/2013 – 4/30/2018
Purpose: The Clinical and Translational Science Award supports Colorado’s institutional home for
research and training in clinical and translational sciences.
Roles: Core Lead, Pragmatic Trials and Dissemination/Implementation Research (20% effort)
Core Lead, Innovation-Corps (I-Corps) training program for commercialization (15% effort)
Amount: $51.7 MM (Total Costs 5 years)
COMPLETED
Implementation Research Agenda: Appropriate Use of Clinical Preventive Services
R13 HS23723-01, AHRQ (PI: Morrato) 11/15/2014–11/14/2016
Purpose: This small conference developed a national implementation science research agenda to address
issues of under-, over- and inequitable use of clinical preventive services in primary care.
Role: PI
Amount: $33,000 (conference costs)
Metabolic Screening: Prioritizing Implementation Strategies in Mental Health 12/1/2012–11/30/2015
R21 MH 097045, NIMH (PI: Morrato)
Purpose: This project investigated provider and practice factors affecting the implementation of diabetes
and dyslipidemia screening guidelines in persons with mental illness taking antipsychotics.
Role: PI (25% effort)
Amount: $275,000 (total direct costs)
Center for Research in Implementation Science and Prevention (CRISP) 10/1/2011 – 9/30/2015
1 P01 HS021138-01, AHRQ (PI: Kempe)
Purpose: This project brought together experts in primary care and public health delivery to conduct
research on ways to increase implementation of clinical preventive services within primary care.
Role: Collaborative Scientific Lead (co-PI equivalent) (20% effort)
Core Lead, Training and Education (10% effort)
Amount: $3,158,296 (direct costs)
Center for Native Oral Health Research (CNOHR). 6/1/2008 –5/31/2015
U54 DE019259-02, National Institute of Dental and Craniofacial Research, NIH (PI: Albino)
Purpose: This Center focused on reducing oral health disparities in American Indians and Alaskan
Natives through community-based interventions
Role: PI, “R21-equivalent” development project. Transferred project after receiving K12 award.
Amount: $10.7 million
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Children’s Outcomes Research (COR) Program 1/1/2007 – 5/31/2015
The Children’s Hospital Research Institute (PI: Kempe)
Purpose: This center program conducted pediatric health outcomes research and mentored clinical faculty.
Role: Associate Director (2009-2013), Co-I (2013-2105)
Core Lead, Comparative Effectiveness Research Core (2010-2013)
Amount: $1.5 million (2007-2011); $2.6 million (2012-2015)
Scalable Architecture for Federated Therapeutic Inquiries Network (SAFTINet) 10/1/2010–9/30/2013
Agency for Healthcare Research and Quality (R01 HS019908-01) (PI: Schilling)
Purpose: This multi-state registry project combined clinical data with Medicaid claims to support patient-
centered comparative effectiveness research with safety-net populations and stakeholders.
Role: Core Lead, CER methods (transferred role when the K-12 award was funded)
Amount: $4.6 million (direct costs)
SocioWorks: Integrated web-platform for social network analysis 9/1/2010 – 8/31/2013
R44 AG038316, National Institute on Aging, NIH (PI: Tien)
Purpose: This SBIR project created a technologically and organizationally scalable web application
toolset for social network methods and their application to improving health and productivity.
Role: Site PI, Demonstration Lead: Policy Application (funded at 20% effort, converted to research
staff support when the K-12 award was funded)
Amount: $78,000 (direct costs for our site). Approx. $2.1 MM (total costs for the award)
Colorado CER and Safety Scholars Program: Mental Health, CVD, and Methods 7/1/2010–6/30/2013
K12 HS019464, AHRQ (PI: Libby)
Purpose: This K12 program in Comparative Effectiveness Research (CER) addressed research capacity
and improve the CER workforce and leadership pools of the future. My project was entitled
“Accelerating the Diffusion of CER Evidence into Clinical Practice”.
Role: CER K12 Scholar PI (75% effort)
Amount: $4.5 million (total direct costs)
Comparative effectiveness of paliperidone palmitate 7/31/2012 – 8/1/2013
when used in a real-world clinical setting
Janssen Pharmaceuticals, Inc. (PI: Morrato)
Purpose: This project disseminated scientific results from a comparative effectiveness research study of a
new long-acting antipsychotic medication in Missouri Medicaid compared
Role: PI (20% effort, converted to research staff support while funded by the K-12 award)
Amount: $50,000 (total direct costs)
Comparative effectiveness of paliperidone palmitate 1/1/2011 – 12/31/2012
when used in a real-world clinical setting
Janssen Pharmaceuticals, Inc. (PI: Lenze)
Purpose: This project described the diffusion a new long-acting antipsychotic medication in Missouri
Medicaid and compare its clinical and costs effectiveness compared to oral medications.
Role: Site PI (20% effort, converted to research staff support when the K12 award was funded)
Amount: $99,000 (total direct costs)
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Prescriber Education Curriculum-Impact and Results (PEC-IR) Study 5/1/2011 – 4/30/2012
MedScape (PI: Parks)
Purpose: This project compared the effectiveness of three continuing education strategies on improving
metabolic screening in Missouri Community Mental Health Centers
Role: Site PI, health services data analysis
Amount: $11,000
Periodontal health in adolescents with Type 1 Diabetes Mellitus 91//2006 – 8/31/2010
MO1-RR00069, NCRR, NIH, Delta Dental Frontier Center, Procter & Gamble (unrestricted gift)
Purpose: This epidemiology study estimated the prevalence of peridontal disease in adolescents with Type
1 diabetes in relationship to oral health knowledge, oral hygiene behaviors and diabetes control
Role: PI (20% effort)
Amount: $150,000 (total direct costs)
Evaluating the impact of FDA warnings and consensus recommendations 9/1/2006 –12/31/2008
on metabolic screening and monitoring for patients initiating atypical antipsychotic medication
Pfizer, Inc.
Purpose: To determine rates and determinants of metabolic testing among patients receiving antipsychotic
medication in 3 Medicaid programs and whether rates changed following drug warnings
Role: PI (25% effort)
Amount: $119,000
Drug risk communication: physician perceptions. 9/1/2005 –8/31/2006
Johns Hopkins Bloomberg School of Public Health, Dissertation Award
Purpose: To qualitatively explore drug safety perceptions and information sources among physicians
Role: PI
Amount: $5,000 (research supplies)
CO-INVESTIGATOR
ACTIVE
IMPlementation to Achieve Clinical Transformation (IMPACT): 09/01/2017-08/31/2022
The Colorado Training Program
1 K12 HL137862-01, NIH / NHLBI (Co-PI: Glasgow, Havranek) Impact Score: 29
Purpose: To develop “T4” (clinical translation to population) scholars through training in key
competencies for dissemination and implementation research and in-depth tailored mentorship.
Role: K12 Faculty (3-5% effort)
Amount: TBD
Reducing Risk Factors for Type 2 Diabetes in American Indian Youth: 9/01/2017-08/31/2022
Tribal Turning Point 1 R01 DK115434-01, NIH / NIDDK (Co-PI: Dabelea, Sauder) Impact Score: 10
Purpose: This RCT evaluates a behavioral intervention on diabetes risk factors in 7-10 year old
American Indian children across three communities, and explores factors related to participant
engagement, program implementation, and potential for dissemination and sustained delivery.
Role: Co-I, dissemination and implementation scientist (8% effort)
Amount: TBD
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Problem-Solving Skills Training for Clinicians 04/15/2015-03/31/2020
Providing Psychosocial Care in Pediatric Oncology
R25 CA183725, NCI/NIH (Co-PIs: Sahler, Noll)
Purpose: This project aims to disseminate via a national training program an evidence-based
psychosocial skills training intervention which identifies coping strategies that facilitate the
adjustment of caregivers learning their child had been diagnosed with cancer.
Role: Co-Investigator, dissemination and implementation scientist (15% effort Year 1; 5% effort
years 2, 3, 4; and 20% effort year 5)
Amount: $310,594 (annual direct-prime)
COMPLETED
Maximizing Care Management Effectiveness in Primary Care 08/01/14-01/31/17
1R18HS022690-01, AHRQ (PI: Holtrop)
Purpose: This study investigated factors affecting care management implementation in primary care in
order to maximize the benefit of this new service in community-based primary care.
Role: Co-Investigator, dissemination and implementation scientist (2% effort)
Amount: $750,000 (total costs)
Pediatric Obesity and Type 2 Diabetes (T2D) 8/1/2015-7/30/2016
in American Indian Youth (PI: Sauder)
Pilot award from the Center for American Indian and Alaska Native Diabetes Translational Research
P30DK092923, NIDDK/NIH (PI: Manson)
Purpose: To investigate sustainable implementation of a pediatric nutrition program within the Navajo
Nation and plan for a larger dissemination and implementation research study.
Role: Co-Investigator, dissemination and implementation scientist (2% effort)
Amount: $50,000 (total)
SAFTINet: Optimizing Value and Achieving Sustainability 09/30/2013 – 03/31/2015
R01 HS022956, AHRQ (PI: Schilling)
Purpose: To enhance the capabilities of an existing data network, the Scalable Architecture for
Federated Translational Inquiries Network (SAFTINet), by improving its ability to conduct
comparative effectiveness research and ensure its financial sustainability.
Role: Co-Investigator, dissemination and implementation scientist (funded at 15%)
Amount: $750,000 (total costs)
Pediatric National Surgical Quality Improvement Program 9/1/2006 – 8/31/2009
American College of Surgeons (Site PI: William Henderson)
Purpose: To provide statistical and epidemiological guidance on protocol development and pilot-testing of
the Pediatric National Surgical Quality Improvement Program (Pediatric NSQIP)
Role: Co-Investigator, statistical core (20% effort)
Amount: $1.03 million (total costs)
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An evaluation of the FDA warnings on antidepressants and suicidality 5/1/2006 – 11/30/2006
on patterns of care for depression in U.S. managed care enrollees.
Eli Lilly and Company. (PI: Robert Valuck)
Purpose: To investigate whether antidepressant drug warnings had an effect on depression diagnosis,
treatment, and monitoring in pediatric and adult populations
Role: Co-Investigator (20% effort)
Amount: $350,000
Atypical antipsychotic treatment patterns in a multi-state 9/1/2004 – 8/31/2006
Medicaid population. Janssen Pharmaceuticals. (PI: Robert Valuck)
Purpose: To estimate the prevalence, determinants, and costs of antipsychotic polypharmacy in 5 states
Role: Co-Investigator (60% effort equivalent as a component of my Fellowship)
Amount: $250,000
CONSULTANT
ACTIVE
Methods Training in Patient-Centered Cancer Outcomes Research 6/1/1014 – 5/31/2019
1 R25 HS 023214-01, AHRQ (PI: Suarez-Almazor)
Purpose: The overall goal of this training program is to increase the nation’s workforce for conducting
cancer-related comparative effectiveness research and patient-centered outcomes research
through an innovative, accessible curriculum tailored to the needs and skills of the participants.
Role: Scientific Advisory Committee
SMINET: Applying Evidence to Improve Care and Outcomes in 7/1/2014-6/30/2018
Severe Mental Illness
1R18HS023258-01, AHRQ (PI: Crystal)
Purpose: SMINET will build on an established multi-state consortium to increase uptake, on a broad
scale, of selected evidence-based practices in the care of persons with severe mental illness that
are particularly high-impact targets for improving long-term health outcomes.
Role: Scientific Advisory Committee
COMPLETED
Building Networks of Engaged Parents for Patient-Centered Pediatric Research 4/1/2015-3/31/2017
Contract 1300-UCD, PCORI (PI: O’Leary)
Purpose: This project engaged patients, parents, clinicians, and other stakeholders in the collaborative
development of research questions and patient-centered research relevant to child health in the
PBRN setting.
Role: Leadership Advisory Board
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RESEARCH RECORD: PHARMACEUTICAL INDUSTRY
THE PROCTER & GAMBLE COMPANY
2000-2002 Azimilide Phase III (Registration) clinical development research program (class III
antiarrhythmia drug).
Role: Global R&D Program Lead
1997-1999 Azimilide Phase IIIb (Commercialization) clinical development and pharmacoeconomic
and epidemiology research program (class III antiarrhythmia drug).
Role: Global R&D Program Lead
1996-1997 Helidac® (bismuth subsalicylate/metronidazole/tetracycline hydrochlorid) Phase IIIb
(Commercialization) consumer research program (stomach/intestinal ulcer antibiotics).
Role: U.S.R&D Launch Lead
1994-1995 Asacol® (Mesalamine Delayed-Release) 5-year clinical development and manufacturing
cost savings program (inflammatory bowel disease drug).
Role: North American Technical Brand Manager
1992-1994 Cholysyl consumer and market understanding research (U.S., Germany, Mexico, and
Japan) (cholesterol-lowering drug).
Role: Global Product Development Lead: market evaluation
1992-1994 Metamucil® (psyllium) consumer understanding research program
Role: U.S. Product Development Team Lead: consumer understanding research
1992 Sunrise Smooth Metamucil® (psyllium) Sugar-Free Regular Flavor national launch
leader (constipation and cholesterol-lowering drug).
Role: U.S. Product Development Launch Lead
1990-1991 FDA approval of cyanoacrylate adhesive for Actisite® (tetracycline HCl). (device used
in combination with periodontitis site-specific antibiotic treatment)
Role: U.S. Product Development Lead
1989-1991 Actisite® (tetracycline HCl) Phase III clinical study (periodontitis site-specific
antibiotic). Pivotal clinical data supporting first regulatory approval in the U.S. and
Europe of site-specific drug therapy for periodontitis
Role: U.S. Product Development Lead
1989 Trade-off (conjoint analysis) study of preferred product attributes for site-specific drugs
to treat periodontitis: Understanding the needs of dentists and periodontists.
Role: PI
1989 Qualitative research study to understand the product needs of dentists and periodontists
for site-specific treatment of periodontitis.
Role: PI
1988 Clinical validation of gingivitis diagnostic testing (leukocyte esterase) using different
sampling methods of gingival crevicular fluid.
Role: PI
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BIBLIOGRAPHY
PEER-REVIEWED JOURNAL ARTICLES – CATEGORIZED BY AREA OF SCHOLARSHIP
Google Scholar H-Index = 20
52 Published articles. 23 first author. 8 senior author. 9 with student/mentees.
ǂ Senior author
§ Manuscript published with students, mentees
* Manuscript had an accompanying press-release or editorial from the journal or received notice from
a secondary medical news outlet (see CV Appendix B)
Mental Health Services Research
1. Morrato EH, Campagna EJ, Brewer SE, Dickinson LM, Thomas DSK, Miller BF, Dearing J,
Druss BG, Lindrooth RC. Metabolic Testing for Adults in a State Medicaid Program taking
Antipsychotics: Remaining Barriers to Achieving Population Health Prevention Goals. JAMA
Psych 2016 May 11. doi: 10.1001/jamapsychiatry.2016.0538. [Epub ahead of print]
2. Morrato EH, Brewer, S, Campagna EJ, Dickinson, LM, Thomas, DSK, Druss BG, Miller B,
Newcomer JW, Lindrooth RC. Glucose Testing for Adults Receiving Antipsychotics: A
Population-Based Prescriber Survey on Behaviors, Attitudes and Barriers in Medicaid Psych Serv
2016 Apr 1:appips201500181. [Epub ahead of print]
3. ǂ § Nicol GN, Campagna EC, Garfield L, Parks JJ, Newcomer JN, Morrato EH. Clinical Setting
and Management Approach Matters: Metabolic Testing Rates in Antipsychotic-Treated Youth
and Adults Psych Serv 2015 1:appips201400428. [Epub ahead of print].
4. ǂ Root ED, Thomas DSK, Campagna EJ, Morrato EH. Adjusting for Geographic Variation in
Observational Comparative Effectiveness Studies: A Case Study of Antipsychotics Using State
Medicaid Data BMC Health Serv Res [2014] BMC Health Services Research. 2014, 14:355 DOI:
10.1186/1472-6963-14-355.
5. Morrato EH, Parks J, Campagna EJ, Muser E, Thomas DS, Fang H, Doshi D. Comparative
effectiveness of injectable paliperidone palmitate versus oral atypical antipsychotics: early
postmarketing evidence. J Comparative Effectiveness Research 2014. Sep 24:1-11. [Epub ahead
of print]
6. ǂ Campagna E, Muser E, Parks J, Morrato EH. Methodological considerations in estimating
adherence and persistence for a long-acting injectable medication. J Manag Care Pharm 2014.
Jul;20(7):756-66.
7. Morrato EH. An update on lipid profile screening in second generation antipsychotic users in
the United States Clinical Lipidology 2012; 7(5): 509-523.
8. Gohlke JM, Dhurandhar EJ, Correll CU, Morrato EH, Newcomer JW, Remington G, Nasrallah
HA, Crystal S, Nicol G, Adipogenic and Metabolic Effects of APDS Conference Speakers,
Allison DB. Frontiers in Psychiatry 2012;3:62. Epub 2012 Jun 28.
9. Druss BG, Zhao L, Von Esenwein S, Morrato EH, Marcus SC. Understanding Excess Mortality
in Persons With Mental Illness: 17-Year Follow Up of a Nationally Representative US Survey.
Medical Care 2011 Jun; 49(6):599-604.
10. Morrato EH, Druss B, Hartung DM, Valuck RJ, Thomas D, Allen RR, Campagna E, Newcomer
JW. Small Area Variation in Metabolic Risk Management for Patients Initiating Second-
Generation Antipsychotics. Pharmacoepidemiology and Drug Safety 2010; 20:66-75. 2010 Nov 15.
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11. *§ Morrato EH, Nicol G, Maahs D, Druss B, Hartung DM, Valuck RJ, Allen RR, Campagna E,
Newcomer JW. Metabolic risk monitoring in children receiving second-generation antipsychotic
drugs Arch Ped and Adolesc Med, 2010 Apr;164(4):344-51.
12. Morrato EH, Newcomer JW, Kamat S, Baser O, Harnett J, Cuffel B. Metabolic screening after
the ADA’s Statement on antipsychotic drugs and diabetes Diabetes Care 2009; 32(6): 1037-1042.
13. Banta JE, Morrato EH, Lee SW, Haviland MG. Retrospective Analysis of Diabetes Care in
California Medicaid Patients with Mental Illness Journal of General Internal Medicine.
Jul;24(7):802-8. Epub 2009 May 5.
14. Morrato EH, Cuffel B, Newcomer JW, Lombard I, Kamat S, Barron J. Metabolic risk status and
second-generation antipsychotic drug selection: A retrospective study of commercially insured
patients. Journal of Clinical Psychopharmacology; 2009; 29(1): 26-32.
15. Morrato EH, Newcomer JW, Allen RR, Valuck RJ. Prevalence of baseline serum glucose and
lipid testing in users of second-generation antipsychotic drugs: A retrospective, population based
study of Medicaid claims data. J Clin Psychiatry. 2008; 69(2):316-22.
16. Valuck RJ, Morrato EH, Dodd S, Oderda G, Haxby DG, Allen RR. How expensive is
antipsychotic polypharmacy? Experience from five state Medicaid programs. Current Medical
Research and Opinion. 2007: 23(10): 2567-2576.
17. Morrato EH, Dodd S, Oderda G, Haxby DG, Allen R, Valuck RJ. Prevalence, utilization
patterns and predictors of antipsychotic polypharmacy: experience from a Multi-State
Medicaid Population (1998-2003). Clinical Therapeutics. 2007. Jan;29(1):183-95.
FDA Regulatory Science – Drug Safety
1. Dew K, Gardner, J, Morrato EH, Norris P, Chamberlain K, Hodgetts D, Gabe J. Public
Engagement and the Role of the Media in Post-Marketing Drug Safety: The Case of Eltroxin®
(levothyroxine) in New Zealand. Critical Public Health 2017
doi:10.1080/09581596.2017.1329520 [online]
2. § Feinstein JA, Morrato EH, Feudtner C. Prioritizing Pediatric Drug Research Using Population-
Level Health Data. JAMA Pediatrics 2017 Jan 1;171(1):7-8. doi:10.1001/jamapediatrics.2016.3462
3. Radawski C, Morrato EH, Hornbuckle K, Bahri P, Smith MY, Juhaeri J, Mol P, Levitan B,
Huang H-Y, Coplan P, Li J on behalf of the BRACE Special Interest Group. Benefit-Risk
Assessment, Communication and Evaluation (BRACE) throughout the Life Cycle of Therapeutic
Products: Overall Perspective and Role of the Pharmacoepidemiologist Pharmacoepidem Oct 12.
doi: 10.1002/pds.3859. [Epub ahead of print]
4. Morrato EH, Smith MY. Integrating risk minimization planning throughout the clinical
development and commercialization lifecycle: an opinion on how drug development could be
improved. Ther Clin Risk Manag 2015 Feb 26;11:339-48. doi: 10.2147/TCRM.S78202.
5. ǂ Smith MY, Morrato EH. Advancing the field of pharmaceutical risk minimisation through
application of implementation science best practices Drug Safety 2014 Jul 9. [Epub ahead of
print]
6. Morrato EH, Allison DB, FDA Approval of Obesity Drugs-- A Difference in Risk-Benefit
Perceptions. JAMA 2012; online Sep 19; 308(11): 1097-1098.
7. § Morrato EH, Ling S. The FDA Drug Safety and Risk Management Advisory Committee: A
Case Study Evaluation of Meeting Frequency, Content and Outcomes Before and After FDAAA.
Medical Care 2012; 50 (11): 970–986.
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8. * Morrato EH, Druss, B, Hartung DM, Valuck RJ, Allen RR, Campagna E, Newcomer JW.
Metabolic testing rates in three state Medicaid programs after FDA Warnings and ADA/APA
Recommendations for Second-Generation Antipsychotic Drugs. Arch Gen Psych 2010;
67(1): 17-24.
9. Morrato EH, Curbow B, Crum R, Nowels C, Feinleib, M. Communicating drug risk to
physicians: challenges and opportunities. International J of Risk & Safety in Medicine 2008;
20(3): 143-154.
10. * Morrato EH, Libby AM, Orton HD, deGruy III, FV, Brent DA, Allen RR, Valuck RJ.
Frequency of provider contact after FDA warning on suicidal risk of antidepressants in children.
Am J Psychiatry. 2007; 10.1176/appi.ajp.2007.07010205.
11. * Libby AM, Brent DJ, Morrato EH, Orton HD, Allen R, Valuck RJ. Pediatric depression
treatment declines after FDA advisory on suicidality risk of SSRI antidepressants. Am J
Psychiatry. 2007: 164: 884-891.
12. Valuck RJ, Libby AM, Orton HD, Morrato EH, Allen RR, Baldessarini RJ. Spillover effects on
treatment of adult depression in primary care after FDA Advisory on risk of pediatric suicidality
with SSRIs. Am J Psychiatry. 2007 Aug; 164(8):1198-1205.
13. Morrato EH, Staffa JA. Effectiveness of risk management plans: a case study of pemoline
using pharmacy claims data. Pharmacoepidemiology and Drug Safety. 2007 16(1):104-12.;
doi 10.1002/pds.1279.
Dissemination and Implementation Science
1. Morrato EH, Rabin B, Proctor J, Cicutto LC, Battaglia CT, Lambert-Kerzner A, Leeman-Castillo
B, Prahl-Wretling M, Nuechterlein BM, Glasgow RE, Kempe A. Bringing it Home: Expanding
the Local Reach of Dissemination and Implementation Training via a University-Based Training
Workshop 2015 Implement Sci 2015 Jul 4;10:94. doi: 10.1186/s13012-015-0281-6.
3. Morrato EH, Concannon TW, Meissner P, Shah ND, Turner BJ. Dissemination and
Implementation of Comparative Effectiveness Evidence: Key Informant Interviews with Clinical
and Translational Science Award Institutions. J Comparative Effectiveness Research 2013; 2(2):
185-194, DOI 10.2217/cer.13.10.
4. § Nicol GE, Morrato EH, Johnson MC, Campagna E, Yingling MD, Pham V, Newcomer JW.
Best Practices: Implementation of a Glucose Screening Program Based on Diffusion of
Innovation Theory Methods. Psychiatr Serv. January 2011; 62(1):12-14.
5. *Concannon TW, Meissner P, Grunbaum JA, McElwee N, Guise J-M, Santa J, Conway PH,
Daudelin D, Morrato EH, Leslie, LK. A New Taxonomy for Stakeholder Engagement in
Patient-Centered Outcomes Research. Journal of General Internal Medicine. EPub 2012 Apr 13.
DOI: 10.1007/s11606-012-2037-1.
Health Services and Health Outcomes Research
1. ǂ Merchant, AT, Nahhas GJ, Wadwa RP, Zhang, J, Tang Y, Johnson LR, Maahs DM, Bishop F,
Teles R, Morrato EH. Periodontal microorganisms and cardiovascular risk markers in youth
with type 1 diabetes and no diabetes J Periodontology . 2016 Apr;87(4):376-84. doi:
10.1902/jop.2015.150531. Epub 2015 Nov 28.
2. *§ Sømme S, Bronsert M, Morrato EH, Ziegler, MM. Frequency and Variety of Inpatient
Pediatric Surgical Procedures in the United States. Pediatrics 2013 Dec;132(6):e1466-72. doi:
10.1542/peds.2013-1243. Epub 2013 Nov 25.
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3. Barnard J, Albright K, Morrato EH, Nowles CT, Benefield EM, Hadley-Miller NA, Kempe A,
Erickson MA. Pediatric Spinal Fusion Surgery and the Transition to Home-Based Care: Provider
Expectations and Caregiver Experiences Health & Social Care in the Community. 2013
Nov;21(6):634-43. doi: 10.1111/hsc.12049. Epub 2013 May 6.
4. Erickson MA, Morrato EH, Campagna E, Benefield E, Miller NH, Kempe A. Variability in
Spinal Surgery Outcomes among Children's Hospitals in the US. J Pediatr Orthop 2013;33:80–90.
5. ǂ* Victoroff MS, Drury B, Campagna ES, Morrato EH. Impact of Electronic Health Records on
Malpractice Claims in a Sample of Physician Offices in Colorado: A Retrospective Cohort Study.
Journal of General Internal Medicine 2012 doi: 10.1007/s11606-012-2283-2.
6. § Sømme S, Bronsert M, Kempe A, Morrato EH, Ziegler M. Alignment of the Training
Curriculum and Surgical Practice: Implications for Competency, Manpower, and Practice
Modeling. Eur Journal of Pediatric Surgery 2012 Feb; 22(1): 74-9 Epub 2012 Mar 20.
7. Merchant AT, Jethwani M, Choi Y-H, Morrato EH, Liese AD, Mayer-Davis E. Oral care
practices and A1C among youth with type 1 and type 2 diabetes. J Periodontology 2011 Dec 5
[Epub ahead of print]
8. § Fox D, Morrato EH, Campagna E, Rees D, Dickinson LM, Partrick D, Kempe A. Outcomes
of Laparoscopic Versus Open Fundoplication in Children's Hospitals: 2005-2008. Pediatrics
2011; 127:872-880; doi: 10.1542/peds.2010-1198.
9. *Merchant AT, Jethwani M, Choi Y-H, Morrato EH, Liese AD, Mayer-Davis E. Associations
between periodontal disease and selected risk factors of early complications among youth with
type 1 and type 2 diabetes: a pilot study. Pediatric Diabetes 2011; doi: 10.1111/j.1399-
5448.2010.00736.x
10. ǂ§ Orlando VA, Johnson LR, Wilson AR, Maahs DM, Wadwa RP, Bishop FK, Dong F, Morrato
EH. Oral Health Knowledge and Behaviors among Adolescents with Type 1 Diabetes. Int J
Dentistry, 2010; 2010:942124. Epub 2010 May 13.
11. Morrato EH, Dillon P, Ziegler MM. Surgical outcomes research: A progression from
performance audits, to assessment of administrative databases, to prospective risk-adjusted
analysis. How far have we come? Curr Opin Pediatr June 1, 2008; 20(3): 320-325.
12. Dillon P, Hammermeister K, Morrato EH, Kempe A, Oldham K, Moss L, Marchildon M,
Ziegler M, Steeger J, Rowell K, Shiloach M, Henderson W. Developing a NSQIP module to
measure outcomes in children’s surgical care: opportunity and challenge Semin in Pediatr Surg
May 1, 2008; 17(2): 131-140.
13. *Morrato EH, Hill JO, Wyatt HR, Ghushchyan V, Sullivan PW. Physical activity in U.S. adults
with diabetes and at-risk for developing diabetes, 2003. Diabetes Care. 2007 Feb;30(2):203-9.
14. Morrato EH, Elias M, Gericke, C. Population-based data for evidence-based health policy
decisions: lessons from three examples of setting and evaluating national health policy in
Australia, the UK, and USA. Journal of Public Health. 2007; doi:10.1093/pubmed/fdm065.
15. Morrato EH, Hill JO, Wyatt HR, Ghushchyan V, Sullivan PW. Are health care professionals
advising patients with diabetes or at-risk for developing diabetes to exercise more? Diabetes
Care. 2006 Mar; 29(3):543-8.
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16. McCollum M, Ellis SL, Morrato EH, Sullivan PW. Prevalence of multiple cardiovascular
risk factors in U.S. adults with diabetes. Current Medical Research and Opinion. 2006;
22(4): 1031-1034.
17. Sullivan PW, Morrato EH, Ghushchyan V, Wyatt HR, Hill JO. Obesity, inactivity and the
prevalence of diabetes and diabetes-related cardiovascular comorbidities in the U.S., 2000-2002.
Diabetes Care. 2005; 28(7): 1599-1603.
EDITORIALS AND COMMENTARIES
1. Morrato EH. The Case for Funding Our National Drug Safety Surveillance System. Medical
Care. 2017 Jun;55(6):543-544. doi: 10.1097/MLR.0000000000000742.
2. Morrato EH Capsule Commentary on Sabbatini et al., Controlling Health Costs: Physician
Responses to Patient Expectations for Medical Care. J Gen Intern Med. 2014 Sep;29(9):1272.
doi: 10.1007/s11606-014-2929-3
3. Experts call for improved FDA Risk Evaluation and Mitigation Strategy Program. Endocrine
Today. January 2014.
4. Morrato EH, Perspective appearing August 28, 2012 in Psychiatric Annals on “Obesity
phenotypes in midlife and cognition in early old age, The Whitehall II cohort study” by Singh-
Manoux A, et al., Neurology, 2012; 79:755-762.
5. Morrato EH, Hartung DM, Lipid profile screening in second-generation antipsychotic users: the
gap between policy and practice. Clin Lipidol 2010;5:299-303
INVITED BOOK CHAPTERS
1. Morrato EH, “Social Science Theory as a Framework for Designing and Evaluating
Pharmaceutical Risk Mitigation Dissemination and Implementation Strategies” in Risk
Management Principles for Devices and Pharmaceuticals: Global Perspectives on the
Benefit:Risk Assessment of Medicinal Products (2nd Edition), ed. W.K. Sietsema, J. M. Sprafka.,
eds. Rockville, MD: Regulatory Affairs Professionals Society (in press).
2. Morrato EH, “Comparative Effectiveness and Health Care Reform, Counterpoint Commentary:
Patient-Centered Outcomes Research: Putting the patient at the center of comparative
effectiveness research” in Debates on U.S. Health Care Reform. Kronenfeld J, Parmet W, Zezza
M, eds. Thousand Oaks, CA: SAGE, 2012. ISBN: 9781412996020.
3. Morrato EH, “Social Science Theory as a Framework for Designing and Evaluating
Pharmaceutical Risk Mitigation Dissemination and Implementation Strategies” in Risk
Management Principles for Devices and Pharmaceuticals: Global Perspectives on the
Benefit:Risk Assessment of Medicinal Products, ed. W.K. Sietsema, J. M. Sprafka., eds.
Rockville, MD: Regulatory Affairs Professionals Society, 2012. ISBN: 978-0-9829320-3-2.
E-BOOKS: IMPLEMENTATION SCIENCE
1. Morrato EH, Rabin B, Cameron C, Glasgow RE. “Users’ Guide to Dissemination and
Implementation in Health for Researchers and Practitioners”. Colorado Research in
Implementation Science Program (CRISP), University of Colorado Denver, Anschutz Medical
Campus. Published October 2014. www.CRISPebooks.org .
2. Morrato EH, Rabin B, Cameron C, Glasgow RE. “Introduction to Pragmatic Clinical Trials”.
Colorado Research in Implementation Science Program (CRISP), University of Colorado Denver,
Anschutz Medical Campus. Published July 2015. www.CRISPebooks.org .
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INVITED BOOK REVIEWS
1. Textbook of Pharmacoepidemiology Edited by Brian L. Strom and Stephen E. Kimmel EH
Morrato American Journal of Epidemiology 2007; doi: 10.1093/aje/kwm215
2. Wade Hampton Frost, Pioneer Epidemiologist 1880-1938: Up to the Mountain by Thomas M.
Daniel. American Journal of Epidemiology. EH Morrato 2005; 162(3): 290-291.
LETTERS TO THE EDITOR
1. Morrato EH, Campagna E, Druss BG, Newcomer JW. Authors’ response: How can we produce
relevant information for decision makers from small area variation studies?
Pharmacoepidemiology and Drug Safety. 2011; 20(7):782–783.
TESTIMONY
1. “Input on Issues and Challenges Associated with the Standardization of REMS” Submitted
September 13, 2013 to the Federal Register: FDA Notice of Public Hearing and Request for
Comments Standardizing and Evaluating REMS, Vol. 78, No. 99, May 22, 2013.
2. On behalf of the Benefit Risk Assessment, Communication, and Evaluation Special Interest Group.
“International Society for Pharmacoepidemiology Response to FDA Questions: Standardization and
Evaluation of Risk Evaluation and Mitigation Strategies (REMS) – Public Meeting on July 25-26,
2013”. Submitted March 2014 to the Federal Register: FDA Notice of Public Hearing and Request
for Comments Standardizing and Evaluating REMS, Vol. 78, No. 99, May 22, 2013.
See: http://www.regulations.gov/#!documentDetail;D=FDA-2013-N-0502-0042
TECHNICAL RESEARCH REPORTS
1. Morrato EH, Campagna E, Fang H, Root ED, Thomas D, Dibert E, Ferre, Stuve P, Parks J,
Newcomer JW. “Effectiveness of Invega Sustenna® in a Medicaid Population: Comparing the
effectiveness of a long-acting paliperidone palmitate versus oral second generation antipsychotics
when used by adult patients with schizophrenia in a real-world clinical environment” for Janssen
Scientific Affairs, LLC. May 14, 2012R21
2. Morrato EH, Allen RR, Kempe A. “Colorado Children’s Healthcare Access Program (CCHAP): 12-
Month Evaluation of the Program (July 1, 2007 – June 30, 2008)” for the Colorado Department of
Health Care Policy and Financing. March 19, 2009
3. Morrato EH, Allen RR, Kempe A. “Colorado Children’s Healthcare Access Program (CCHAP):
Preliminary Evaluation of the Program (July 1, 2007 – December 31, 2007)” for the Colorado
Department of Health Care Policy and Financing. October 31, 2008
4. Valuck RJ, Libby AM, Morrato EH, Orton H, Allen R. “An evaluation of the FDA warnings on
antidepressants and suicidality on patterns of care for depression in U.S. managed care enrollees” for
Eli Lilly and Company. November 28, 2006.
5. Valuck RJ, Morrato EH, Allen RR. “Atypical Antipsychotic Treatment Patterns in a Multi-State
Medicaid Population (1998-2003)” for Ortho-McNeil, Janssen. March 2006.
6. Valuck RJ, Morrato EH. “Escitalopram vs. citalopram: a comparison of dosing and titration in
community-based clinical practices” for Forest Laboratories. December 2004.
ACKNOWLEDGMENT
1. Newman MG, Kornman KS, Doherty FM. A 6-Month Multi-Center Evaluation of Adjunctive
Tetracycline Fiber Therapy Used in Conjunction with Scaling and Root Planning in Maintenance
Patients: Clinical Results. J Periodontol. 1994; 65(7):685-91.
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PUBLISHED AND PRESENTED RESEARCH ABSTRACTS
ǂ Senior author
§ Presentation by students, mentees
1. § ǂ McNeal DM, Sahler OJ, Noll R, Fairclough D, Voll M, Morrato EH. Improving institutional and
provider sustainability of an evidence-based psychosocial intervention in pediatric oncology. Oral
presentation at the 10th Annual Conference on the Science of Dissemination and Implementation in
Health, Arlington, VA, December 4-5, 2017.
2. ǂ Lennox L, Schuster A, Morrato EH. Designing for dissemination: Characteristics of CTSA hubs as
adopters of clinical and translational science innovation. Poster presentation at the 10th Annual
Conference on the Science of Dissemination and Implementation in Health, Arlington, VA, December
4-5, 2017.
3. § ǂ Johnson RK, Thomas DSK, Campagna EC, Morrato EH. Use of Geospatial Analysis to Examine
Heterogeneity of Diabetes Risk Management Integration into Routine Healthcare for Adults Taking
Antipsychotics. Poster presentation at the 32nd International Conference on Pharmacoepidemiology
& Therapeutic Risk Management (ICPE), Montreal, Canada, August 25-28, 2017.
4. § Lind KE, Hildreth K, Lindrooth RC, Crane L, Morrato EH, Perraillon M. The Impact of Medicare
Part D on Ethnoracial Disparities in Anti-Dementia Medication Utilization. AcademyHealth 2017
Annual Research Meeting, New Orleans, LA, June 25-27, 2017.
5. § Lind KE, Hildreth K, Lindrooth RC, Crane L, Morrato EH, Perraillon M. Ethnoracial Disparities
in Medicare Annual Wellness Visit Utilization: Evidence from a Nationally Representative Database.
AcademyHealth 2017 Annual Research Meeting, New Orleans, LA, June 25-27, 2017.
6. Wasko M, Conway B, Morrato EH, Love S, Hafer N, Kenyon N, Bahti P, Rajguru S, Zonie S, Faye
J. Toward Entrepreneurial Training for Clinical and Translational Investigators: Lessons Learned in
Team-Based Customer and Stakeholder Discovery. Association for Clinical and Translational
Science. Translational Science 2017. Washington, D.C., April 19-21, 2017.
7. § Mulvahill M, Morrato EH, Carlson N. Going to Scale: Disseminating Statistical Software and
Methods in Biomedical Research. Association for Clinical and Translational Science. Translational
Science 2017. Washington, D.C., April 19-21, 2017.
8. Morrato EH, Fairclough D, Noll R, Voll M, Sahler OJ. Strategies for Promoting National Adoption
of Psychosocial Evidence-Based Care in Pediatric Oncology Centers. Poster presentation at the 9th
Annual Conference on the Science of Dissemination and Implementation, Washington, D.C.,
December 14-15, 2016.
9. Holtrop JS, Ruland S, Diaz S, Morrato EH, Jones ES. Using Social Network Analysis as a Means to
Plan and Evaluate the Impact of Health Care Interventions on Communication Networks. Poster
presentation at the 9th Annual Conference on the Science of Dissemination and Implementation,
Washington, D.C., December 14-15, 2016.
10. Holtrop JS, Ruland S, Diaz S, Morrato EH, Jones ES. Using social network analysis to examine the
effect of care management program structure on chronic disease communication. Oral presentation at
the 44th North American Primary Care Group (NAPCG) Annual Meeting, Colorado Springs, CO,
November 12-16, 2016.
11. Morrato EH, Campagna EC, Brewer SE. Programmatic Efficiency of a Pharmaceutical Risk
Management Program: Outcomes from Diabetes Screening of Adults Receiving Antipsychotics.
Poster presentation at the 32nd International Conference on Pharmacoepidemiology & Therapeutic
Risk Management, Dublin, Ireland, August 25-28, 2016.
12. § ǂ Brewer SE, Campagna EC, Morrato EH. Regulatory Considerations for Knowledge, Attitude,
and Belief Surveys: A Systematic Review of Physician Survey Response. Poster presentation at the
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32nd International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE),
Dublin, Ireland, August 25-28, 2016.
13. Morrato EH, Sheridan S, Miller T. Implementation of Appropriate Use of Clinical Preventive
Services: Setting a National Research Agenda. Symposium presentation at the Oral presentation at the
2015 AHRQ Research Conference, Crystal City, VA. October 6–8, 2015.
14. Morrato EH, Campagna E, Brewer S, Dickinson LM, Thomas DSK, Lindrooth R. After a Decade of
Risk Communication on Diabetes Risks Associated with Antipsychotic Drugs: Where Do We Stand
on Prescriber Attitudes and Behaviors? Pharmacoepidemiol Drug Saf. 2015 Aug;24(S1: A760). Oral
presentation at the 31st International Conference on Pharmacoepidemiology & Therapeutic Risk
Management (ICPE), Boston, MA. August 22-26, 2015
15. Morrato EH, Campagna E, Brewer S, Dickinson LM, Thomas DSK, Lindrooth R. Diabetes Testing
for Adults Taking Antipsychotic Drugs: Where To Target Risk Minimization Interventions.
Pharmacoepidemiol Drug Saf. 2015 Aug;24(S1: A805). Selected “Best Poster” in the Spotlight Poster
Session-Benefit Risk Assessment, Communication and Evaluation (BRACE) at the 31st
International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE),
Boston, MA. August 22-26, 2015.
16. Morrato EH, Campagna EJ, Brewer S, Lindrooth RC, Thomas DSK, Dickinson LM, Dearing JW,
Driver R, Druss B, Miller B, Newcomer JW, Parks JJ. Prioritizing Implementation Strategies for
Population Health using Market Segmentation: Diabetes Screening for Adults taking Antipsychotics in
Missouri Medicaid. Poster presentation at the 7th Annual Conference on the Science of Dissemination
and Implementation, Bethesda, MD. December 8-9, 2014.
17. Morrato EH, Rabin B, Proctor J, Cicutto LC, Battaglia C, Lambert-Kerzner A, Leeman-Castillo B,
Prahl-Wretling M, Buckley B, Glasgow RE, Kempe A. Bringing it Home: Expanding the Reach and
Spread of Dissemination and Implementation (D&I) Training. Poster presentation at the 7th Annual
Conference on the Science of Dissemination and Implementation, Bethesda, MD. December 8-9, 2014.
18. Morrato EH, Campagna EJ, Dibert E, Parks J. Diabetes Screening of Adults Receiving
Antipsychotics: A U.S. State Survey of Prescribers. presentation at the 29th International Conference
on Pharmacoepidemiology and Therapeutic Risk Management, Montreal, Canada, August 25-28,
2013.
19. § ǂ Garfield LD, Campagna EJ, Nicol GE, Scherrer JF, Ganeshra N, Parks J, Morrato EH.
Metabolic Risk and Screening in CMHC Patients Starting SGAs in MO Medicaid. Poster presentation
at the 29th International Conference on Pharmacoepidemiology and Therapeutic Risk Management,
Montreal, Canada, August 25-28, 2013.
20. ǂ Wilson AW, Johnson L, Wadwa RP, Maahs D, Haustein V, Bishop F, Morrato EH. ”Early
Periodontal Disease in Adolescents with Type I Diabetes”. J Dent Res Vol 92 (Special Issue A):
abstract 340, 2013 (www.iadr.org).
21. ǂ Campagna E, Muser E, Newcomer JW, Parks J, Morrato EH. "Methodological Considerations in
Estimating Drug Adherence for a Long-Acting Injectable Medication". Poster presentation at the 28th
International Conference on Pharmacoepidemiology and Therapeutic Risk Management, Barcelona,
Spain, August 23-26, 2012.
22. ǂ Root ED, Thomas D, Campagna EJ, Newcomer JW, Parks J, Morrato EH. "Geospatial Variation
in Drug Utilization and the Potential for Confounding by Geography". Poster presentation at the 28th
International Conference on Pharmacoepidemiology and Therapeutic Risk Management, Barcelona,
Spain, August 23-26, 2012.
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23. Merchant AT, Morrato EH, Wadwa RP, Maahs DM, Teles R, Johnson L, Bishop F, Zhang J.
“Periodontal Microorganisms in Youth With and Without Type 1 Diabetes”. Poster Presentation at
the American Diabetes Association’s 72nd Scientific Sessions, Philadelphia, PA, June 8-12, 2012.
24. Morrato EH, Campagna E, Parks J, Stuve P, Thomas D, Fang H, Dilbert, Muser E, Newcomer JW.
“Characteristics of Medicaid patients initiating paliperidone palmitate compared with oral atypical
antipsychotics”. Poster presentation at the American Psychiatric Association’s 165th Annual Meeting,
Philadelphia, PA, May 5-9, 2012.
25. ǂ Newcomer JW, Campagna E, Parks J, Stuve P, Thomas D, Fang H, Dilbert, Muser E , Morrato EH.
“Drug utilization patterns for paliperidone palmitate in Medicaid patients”. Poster presentation at the
American Psychiatric Association’s 165th Annual Meeting, Philadelphia, PA, May 5-9, 2012.
26. Morrato EH, Dibert E, Parks J, Jones EC, Green M, Tien A. “Linking Drug Prescriber Behaviors to
Peer Influence Networks”. Oral presentation at the International Network for Social Network
Conference (Sunbelt XXXII), Redondo Beach, CA, March 12-18, 2012.
27. Somme S, Bronsert M, Morrato EH, Ziegler MM. “U.S. Prevalence of Paediatric Surgical
Procedures”. Oral presentation at the 2011 British Association of Paediatric Surgeons (BAPS)
International Congress, Belfast, Ireland, July 19-22, 2011.
28. § Nicol GE, Morrato EH, Johnson MC, Campagna EC, Yingling MD, Pham V, Newcomer JW.
“Successful Implementation of a Glucose Monitoring Program in a Community Mental Health
Setting”. Poster presentation at the 2010 Institute on Psychiatric Services, Boston, MA, October 14-
17, 2010.
29. Morrato EH, Orlando VA, Johnson LR, Wilson AR, Maahs DM, Bishop FK, Dong F, Merchant A,
Wadwa RP. “Questions Concerning Periodontal Disease Prevalence in Adolescents with Type 1
Diabetes”. Poster presentation selected as one of the top 100 posters showcased in the Presidents
Poster Session and Reception at the 70th Scientific Sessions of the American Diabetes Association,
Orlando, FL June 25-29, 2010.
30. § ǂ Orlando VA, Johnson LR, Wilson AR, Maahs DM, Wadwa RP, Bishop FK, Dong F, Morrato
EH. “Oral Health Knowledge and Behaviors among Adolescents with Type 1 Diabetes”. Poster
presentation featured in the poster tour entitled “Pediatrics – Type 1 Diabetes – Care and Outcomes”
at the 70th Scientific Sessions of the American Diabetes Association, Orlando, FL June 25-29, 2010.
31. § Nicol GE, Morrato EH, Johnson MC, Campagna EC, Yingling MD, Pham V, Newcomer JW.
“Successful Implementation of a Glucose Monitoring Program in a Community Mental Health
Setting”. Poster presentation at the 2010 American Psychiatric Association Annual Meeting, New
Orleans, LA, May 22-26, 2010.
32. Erickson MA, Barnard JG, Morrato EH, Nowels CT, Benefield EM, Hadley-Miller NA, Kempe A.
“Management of Surgical Risk in High Risk pediatric Patients: Provider and Family Caregiver
Experiences of Spinal Fusion Surgery and Care Program” Poster presentation at the Annual Meeting
of the Pediatric Orthopaedic Society of North America, May 4-7, 2010, Waikoloa , HI.
33. Erickson MA, Barnard JG, Morrato EH, Nowels CT, Benefield EM, Hadley-Miller NA, Kempe A.
“Quality of Life for Children with Neuromuscular Scoliosis Two-Years after Spinal Fusion Surgery”
Poster presentation at the Annual Meeting of the Pediatric Orthopaedic Society of North America,
May 4-7, 2010, Waikoloa , HI.
34. Barnard JG, Morrato EH, Benefield EM, Hadley-Miller NA, Kempe A, Erickson MA. “Quality of
Life for Children with Neuromuscular Scoliosis", Poster presentation at the 2010 Pediatric Academic
Societies' Annual Meeting, May 1-4, 2010, Vancouver, BC, Canada.
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35. Barnard JG, Morrato EH, Benefield EM, Hadley-Miller NA, Kempe A, Erickson MA. Quality of
life for children with neuromuscular scoliosis. Poster presentation at the 2009 Annual Meeting of the
International Society for Quality of Life Research, New Orleans, LA, October 28-31, 2009.
36. Morrato EH, Druss B, Hartung DM, Valuck RJ, Thomas D, Allen RR, Campagna E, Newcomer JW.
Determinants of metabolic testing for patients treated with second-generation antipsychotics after the
FDA diabetes Warning. Oral presentation at the 25th Anniversary International Conference on
Pharmacoepidemiology and Therapeutic Risk Management, Providence, RI, August 16-19, 2009.
Pharmacoepidemiology and Drug Safety. 2009.
37. Morrato EH, Nicol G, Druss B, Hartung DM, Valuck RJ, Allen RR, Campagna E, Newcomer JW.
Metabolic risk mitigation in children receiving antipsychotics. Poster presentation at the 25th
Anniversary International Conference on Pharmacoepidemiology and Therapeutic Risk Management,
Providence, RI, August 16-19, 2009. Pharmacoepidemiology and Drug Safety. 2009.
38. Morrato EH, Druss, B, Hartung DM, Valuck RJ, Allen RR, Campagna E, Newcomer JW. Metabolic
testing rates in three state Medicaid programs after FDA Warnings on Antipsychotic Drugs and
Diabetes. Poster presentation at the 2009 American Psychiatric Association Annual Meeting, San
Francisco, CA, May 16-19, 2009.
39. Barnard JG, Erickson MA, Morrato EH, Hadley-Miller NA, Benefield EM, Nowels CT, Kempe A.
Managing Surgical Risk and Post-Discharge Needs in Special Needs Children with Neuromuscular
Scoliosis: The High-Risk Pathway. Poster presentation at the 2009 Pediatric Academic Societies’
Annual Meeting, Baltimore, MD, May 2-5, 2009.
40. Erickson MA, Miller N, Kempe A, Morrato EH, Benefield E. Benton K. Variability in Spinal
Surgery Outcomes among Children s Hospitals in the U.S. Oral presentation to be presented at the
2009 American Academy of Orthopedic Surgeons (AAOS) Annual Meeting, Las Vegas, NV, February
25-28, 2009.
41. § ǂ Flake C, Johnson L, Orlando V, Bishop F, Wadwa P, Wilson A, Maas, D, Morrato EH.
Periodontal health status of adolescents with type 1 diabetes. Poster presentation at the 25th Annual
Research Day at the School of Dental Medicine. February 18, 2009. University of Colorado Denver,
Aurora, CO.
42. Morrato EH, Newcomer JW, Kamat S, Baser O, Harnett J, Cuffel B. Metabolic testing after the
FDA warning on atypical antipsychotic drugs and diabetes risk. Oral presentation at the 24th
International Conference on Pharmacoepidemiology and Therapeutic Risk Management. August 17-
20, 2008. Copenhagen, Denmark. Pharmacoepidemiology and Drug Safety. 2008 17: S266.
43. Morrato EH, Partrick D, Sullivan PW, Ghushchyan V, Kempe A. Prevalence of reflux disorders and
antireflux medication in U.S. children. Poster to be presented at the 24th International Conference on
Pharmacoepidemiology and Therapeutic Risk Management. August 17-20, 2008. Copenhagen,
Denmark. Pharmacoepidemiology and Drug Safety. 2008 17: S204.
44. Morrato EH, Erickson M, Beaty B; Benton K; Benefield E, Kempe, A. Variability in surgical
outcomes for spinal fusion surgery in U.S. children’s hospitals. Oral presentation presented at the
Health Services Epidemiology Spotlight Session at the Society for Epidemiology Research
Conference, June 24-27, 2008, Chicago, IL. Am J Epidemol. 2008; 167(Suppl): S40.
45. Partrick DA, Morrato EH, Kempe A, Beaty B, Roach JP, Ziegler MM. National frequency of
antireflux procedures and gastrostomy. Analysis of hospital type, patient age, and presence of
neurologic impairment. Oral presentation at the Pacific Association of Pediatric Surgeons 41st
Annual Meeting. June 29-July 3, 2008, Jackson Hole, WY.
46. Morrato EH, Newcomer JW, Kamat S, Baser O, Harnett J, Cuffel B. Metabolic screening before and
after the ADA Consensus Statement on Antipsychotic Drugs and Risk of Diabetes and Dyslipidemia.
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Poster presented at the American Diabetes Association’s 68th Scientific Sessions. June 6-10, 2008,
San Francisco, CA. Diabetes. 2008; 57(Suppl 1): A279.
47. Morrato EH, Newcomer JW, Kamat S, Baser O, Harnett J, Cuffel B. Impact of the atypical
antipsychotic FDA Warning on risk of hyperglycemia and diabetes and metabolic monitoring
practices. Poster to be presented at the 48th Annual NCDEU Meeting, co-sponsored by the National
Institute of Mental Health (NIMH) and the American Society of Clinical Psychopharmacology
(ASCP). May 27-30, 2008, Phoenix Arizona.
48. Fox D, Morrato EH, Partrick D, Bruny J, Benton K, Kempe A. National trends regarding
fundoplication in neurologically impaired children. Poster presented at the Pediatric Academic
Societies’ & Asian Society for Pediatric Research Joint Meeting. Honolulu, HI, May 3-6, 2008.
49. Morrato EH, Newcomer JW, Kamat S, Baser O, Harnett J, Cuffel B. Trends in annual metabolic screening
for patients taking second-generation antipsychotic medications. Poster presented at the 161st Annual
Meeting of the American Psychiatric Association Annual Meeting. May 3-8, 2008, Washington, D.C.
50. ǂ Benefield E, Erickson MA, Morrato EH. Implementing a protocol for high risk children undergoing
surgery: How do you make it work? Poster presented at the 18th Annual Convention of the Society for
Pediatric Nurses. April 4-6, 2008, Denver, CO.
51. Partrick DA, Morrato EH, Roach JP, Ziegler, MM. The national frequency of gastrointestinal pediatric
surgery in hospitalized neonates. Oral presentation presented at the 3rd Annual Academic Surgical
Congress. February 13-15, 2008, Huntington Beach, CA.
52. Banta JE, Morrato EH, Lee SW. Diabetes care among Medicaid psychiatric patients. 135th Annual
Meeting of the American Public Health Association. November 3 – 7, 2007, Washington, D.C.
53. Morrato EH, Cuffel B, Newcomer JW, Lombardo I, Kamat S, Barron J. Effect of metabolic risk status on
atypical antipsychotic treatment choice. 160th Annual Meeting of the American Psychiatric Association.
May 19-24, 2007, San Diego, CA.
54. Morrato EH, Curbow B, Nowels C, Feinleib M. Physician sources and perceptions of drug risk
communication. Pharmacoepidemiology and Drug Safety. 2006;15 (Suppl 1): S189.
55. Morrato EH, Feinleib M, Valuck RJ. Changes in liver function testing following the nefazodone
boxed warning. Pharmacoepidemiology and Drug Safety. 2006;15 (Suppl 1): S139.
56. Morrato EH, Feinleib M, Valuck RJ. Characteristics of nefazodone patients receiving baseline liver
function testing. Pharmacoepidemiology and Drug Safety. 2006;15 (Suppl 1): S139.
57. Morrato EH, Newcomer JW, Allen RR, and Valuck RJ. Atypical antipsychotics and diabetes testing:
a four-state Medicaid study. Diabetes. 2006; 55 (Supplement 1).
58. Morrato EH, Newcomer JW, Allen RR, and Valuck RJ on behalf of the Medicaid Pharmacotherapy
Research Consortium. Atypical antipsychotics and metabolic screening: a four-state Medicaid study.
159th Annual Meeting of the American Psychiatric Association Annual Meeting. May 20-25, 2006.
Toronto, Canada.
59. RJ Valuck, EH Morrato, SL Dodd and RR Allen on behalf of the Medicaid Pharmacotherapy
Research Consortium. Antipsychotic utilization: a six-state Medicaid study. 159th Annual Meeting of
the American Psychiatric Association Annual Meeting. Toronto, Canada. May 20-25, 2006.
60. RJ Valuck, EH Morrato, SL Dodd and RR Allen on behalf of the Medicaid Pharmacotherapy
Research Consortium. Antipsychotic polypharmacy costs: a five-state Medicaid study. Value in
Health. 2006; 9(3):A70.
61. Valuck RJ, Libby AM, Morrato EH, Oquenda MA, Brown H, Gibbons RD. Antidepressant
treatment and risk of suicide attempt by adults with major depressive disorder: a propensity-adjusted
retrospective cohort study. Neuropsychopharmacology. 2005: 30 (Supplement 1): S242.
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62. McCollum M, Ellis SE, Morrato EH, Ghushchyan V, Sullivan PW. Prevalence of cardiovascular
risk factors among people with and without diabetes and CHD. American College of Clinical
Pharmacy Annual Meeting. San Francisco, CA. October 22-26, 2005.
63. Valuck RJ, Morrato EH, Allen R, Dodd S. Atypical antipsychotic treatment patterns in six Medicaid
fee-for-service populations. The 2005 National Medicaid Summit. Park City, UT. September 29-
October 1, 2005.
64. Morrato EH, Feinleib M, Valuck RJ. Impact of nefazodone relabeling: changes in prescriber mix
and prescribing volume. Pharmacoepidemiology and Drug Safety. 2005; 14 (Supplement 1).
65. Morrato EH, Sullivan PW, Ghushchyan V, Wyatt HR, Hill JO. Prevalence of diabetes with
increasing adiposity and inactivity in U.S. adults: the Medical Expenditure Panel Survey 2000-
2002. Diabetes. 2005; 54 (Supplement 1): A259.
66. Morrato EH, Sullivan PW, Ghushchyan V, Wyatt HR, Hill JO. Physical activity and diabetes in
U.S. adults: the Medical Expenditure Panel Survey 2000-2002. Diabetes. 2005; 54 (Supplement
1): A254 .
67. Morrato EH, Valuck RJ. Impact of relabeling on nefazodone prescribing: a risk minimization
evaluation. Value in Health. 2005; 8(3): 395.
68. Morrato EH, Staffa JA. Analysis of longitudinal claims data to examine first and second-line use
of pemoline (Cylert®). Value in Health. 2004; 7(3): 282.
69. Morrato EH. Pediatric Drug Labeling Policy: Characteristics of Drugs Granted Exclusivity.
University of Colorado Health Sciences 21st Annual Epidemiology Conference, February 2003.
70. Kerr, CR, Morrato, EH, Humphries, KH et al. Limitations to antiarrhythmic dug use in patients with
atrial fibrillation: Insights from the Canadian Registry of Atrial Fibrillation. North American Society
for Pacing and Electrophysiology Conference, May 2001.
71. Bhattacharyya SK, Tomondy P, Huber D, Morrato EH. Resource utilization for side-effects of
antiarrhythmic drugs. DIA 36th Annual Meeting, June 2000.
72. ǂ Bhattacharyya SK, Tomondy P, Huber D, Morrato EH. Outpatient resource utilization of patients
with atrial fibrillation or flutter related to recurrence and maintenance of normal sinus rhythm. DIA
36th Annual Meeting, June 2000.
73. ǂ Bhattacharyya SK, Morrato EH. Costs of the treatment of side effects of antiarrhythmic drugs in
the USA. International Society for Pharmacoeconomic and Outcomes Research 5th Annual
International Meeting, May, 2000.
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Appendix A. U.S. Food and Drug Administrative Advisory Service
FDA advisory committees are established to contribute scientific expertise which supports the FDA's mission of
protecting and promoting the public health. Since 2008, I have been invited to contribute my expertise in drug
safety and risk management implementation on 51 advisory committees and 7 expert panels and workshops.
I served for four years as a standing member of the Drug Safety and Risk Management Advisory Committee
(2009-2013) during the critical implementation period of the 2007 Food and Drug Administration Amendments
Act (FDAAA) which expanded FDA’s drug safety regulatory authority and oversight of Risk Evaluation and
Mitigation Strategies (REMS). I was subsequently invited to serve a second advisory term as a standing
committee member for the Pulmonary-Allergy Drugs Advisory Committee (2014-2018) and in 2017 was invited
to serve as the Chair of the Committee.
PULMONARY-ALLERGY DRUGS ADVISORY COMMITTEE
The Committee reviews and evaluates data concerning the safety and effectiveness of marketed and
investigational human drug products for use in the treatment of pulmonary disease and diseases with allergic
and/or immunologic mechanisms and makes recommendations to the Commissioner of Food and Drugs.
2017-2018 Chair
2014-2018 Standing Committee Member
Summary of Meeting Topics
1. Review of supplemental new drug application for ivacaflor oral tablets for the treatment of cystic fibrosis
in patients 6 years and older with an R117H mutation in the cystic fibrosis transmembrane conductance
regulator (CFTR) gene. (Oct 2014)
2. Review of supplemental new drug application for fluticasone furoate and vilanterol for the once daily
maintenance treatment of asthma in patients 12 years of age and older. (Mar 2015)
3. Review of new drug application lumacaftor/ivacaftor oral tablets for the treatment of cystic fibrosis in
patients age 12 years and older who are homozygous for the F508del mutation in the cystic fibrosis
transmembrane conductance regulator (CFTR) gene. (May 2015)
4. Review biologics license application for mepolizumab as add-on maintenance treatment in patients 12
years and older with severe eosinophilic asthma. (June 2015)
5. Review biologics license application for reslizumab for injection as add-on maintenance treatment in
patients 12 years and older with severe eosinophilic asthma. (December 2015)
6. Review of the safety of codeine in children 18 years of age and younger. (December 2015)
DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE
The Committee advises the Commissioner of Food and Drugs on risk management, risk communication, and
quantitative evaluation of spontaneous reports for drugs for human use and for any other product for which the
Food and Drug Administration has regulatory responsibility. The Committee also advises the Commissioner of
Food and Drugs regarding the scientific and medical evaluation of all information gathered by the Department of
Health and Human Services and the Department of Justice with regard to safety, efficacy, and abuse potential of
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drugs or other substances, and recommends actions to be taken by the Department of Health and Human Services
with regard to the marketing, investigation, and control of such drugs or other substances.
2011-2013 Standing Committee Member
Summary of Meeting Topics
1. How to address the public health problem of liver injury related to the use of acetaminophen in over-the-
counter and prescription products (Jun 2009)
2. Review of EXALGO, a modified-release hydromorphone drug product (Sep 2009)
3. Review of OXYCONTIN, a re-formulated oxycodone controlled-release drug product designed to reduce
misuse and abuse (Sep 2009)
4. Review of AMAYA, a new drug product to improve walking ability in individuals with multiple sclerosis
(Oct 2009)
5. Review of everolimus, a new drug product for patients with kidney transplants to prevent rejection of the
transplanted kidney (Dec 2009)
6. Review of post-marketing safety related to FDA approved gadolinium-based contrast agents used with
magnetic resonance imaging scans (Dec 2009)
7. Review of belatacept injectable, a new biologics product to be used in patients with kidney transplants to
prevent rejection of the transplanted kidney (Mar 2010)
8. Design of medical research studies to evaluate serious asthma outcomes (such as hospitalizations,
intubation, or death) with the use of the class of asthma medications known as long acting beta-2
adrenergic agonists (LABAs) (Mar 2010)
9. Review of ACUROX (oxycodone/niacin), a new combination drug product designed to reduce misuse
and abuse (Apr 2010)
10. Cardiovascular safety of AVANDIA (rosiglitazone) for blood glucose control in adults with type 2
diabetes mellitus and whether it should remain on the market. (Jul 2010)
11. Review of QNEXA (phentermine/topiramate), a new combination drug product for the treatment of
obesity and weight management (Jul 2010)
12. Risk Evaluation and Mitigation Strategies (REMS) for the therapeutic class of extended-release and long-
acting opioid analgesics (Jul 2010)
13. Review of CYMBALTA (duloxetine) for the treatment of chronic pain (Aug 2010)
14. Review of abuse potential of dextromethorphan, the public health benefits and risks of dextromethorphan
use as a cough suppressant in prescription and non-prescription drugs, and whether it should be a
scheduled narcotic (Sep 2010)
15. Postmarketing studies of OxyContin and Embeda to assess whether product-specific properties intended
to discourage misuse and abuse result in a decrease in risks and consequences (Oct 2010)
16. Review of CONTRAVE (naltrexone/bupropion), a new combination drug product for the treatment of
obesity and weight management (Dec 2010)
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17. Safety considerations of ultrasound contrast agents, including the results of required post-marketing
safety studies and data from post-marketing surveillance (May 2011)
18. Drug development of an investigational gastroenterology drug, closed to the public to permit the
discussion and review of trade secret and/or confidential commercial information (Jul 2011)
19. Benefits and risks of long-term bisphosphonate use for the treatment and prevention of osteoporosis in
light of the emergence of the safety concerns of osteonecrosis of the jaw and atypical femur fractures that
may be associated with the long-term use of bisphosphonates (Sep 2011)
20. REMS program for isotretinoin (iPLEDGE) as an example of a REMS that has Elements to Assure Safe
Use (ETASU) and general issues related to the impact of REMS with ETASU on the healthcare system
and patient access, such as how programs with ETASU can be better integrated into existing health
systems. (Dec 2011)
21. Benefits and risks of drospirenone-containing oral contraceptives in light of the emerging safety concern
that the risk of venous thromboembolism because it may be higher compared to oral contraceptives that
contain the progestin, levonorgestrel (Dec 2011)
22. Benefits and risks of ORTHO EVRA (norelgestromin/ethinyl estradiol transdermal system) for the
prevention of pregnancy. Specifically, the possibly increased risk of thrombotic and thromboembolic
events compared to women who use commonly prescribed birth control pills, as suggested by
postmarketing studies. (Dec 2011)
23. Safety and efficacy of new drug application ADASUVE (loxapine) inhalation powder for the acute
treatment of agitation associated with schizophrenia or bipolar I disorder in adults. (Dec 2011)
24. Safety and efficacy of new drug application (NDA) 22-580, proposed trade name QNEXA
(phentermine/topiramate), as an adjunct to diet and exercise for weight management (Feb 2012)
25. To determine whether reports of joint destruction represent a safety signal related to the anti-nerve growth
factor (Anti-NGF) class of drugs, and whether the risk benefit balance for these drugs favors continued
development of the drugs as analgesics. (Mar 2012)
26. Advice on types of consumer studies needed to assess proper use of a MedKit containing doxycycline to
be taken in the event of anthrax exposure. (Apr 2012)
27. Efficacy supplement for TRUVADA (emtricitabine/tenofovir disoproxil fumarate), for an indication for
pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection (May 2012)
28. Safety and efficacy for safety and efficacy NDA 203441, GATTEX (teduglutide), for the treatment of
adult patients with short bowel syndrome. (October 2012)
29. Risk management of teratogens, some of which have Risk Evaluation and Mitigation Strategies with
Elements to Ensure Safe Use (ETASU) (December 2012)
30. Public health benefits and risks (including the potential for abuse of drugs containing hydrocodone) and
the impact of rescheduling these hydrocodone products from Controlled Substance Schedule III to
Schedule II narcotics (January 2013)
31. Efficacy and safety of Aveed (testosterone undecanoate, intramuscular injection) (April 2013)
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OTHER FDA ADVISORY COMMITTEES
Invited to contribute expertise on drug safety, risk communication and risk management implementation
2008 - Temporary Voting Committee Member
Summary of Meeting Topics
1. Review of the results of an independent re-adjudication of the RECORD (Rosiglitazone Evaluated for
Cardiovascular Outcomes and Regulation of Glycemia in Diabetes) trial, (June 2013)
2. Review of the Lotronex (alosteron hydrochloride) Risk Evaluation and Mitigation Strategies program (Jul
2013)
3. Review of tolvaptan tablets slowing kidney disease in adults at risk of rapidly progressing autosomal
dominant polycystic kidney disease (Aug 2013)
4. Review of vedolizumab for ulcerative colitis and Crohn’s disease (Dec 2013)
5. Review of safety data concerning serious neuropsychiatric adverse events with CHANTIX (varenicline)
for smoking cessation (Oct 2014)
6. Review of a new drug application, oxycodone immediate-release tablets, and abuse-deterrent properties
(Sep 2015)
7. Review of new drug application, oxycodone extended-release capsules, and abuse-deterrent properties
(Sep 2015)
8. Review results from assessments of the extended-release and long-acting (ER/LA) Opioid Analgesics
REMS. (May 2016)
9. Review new drug application, benzhydrocodone/acetaminophen, and its abuse-deterrent properties (May
2016)
10. Review new drug application, hydrocodone bitartrate extended-release, and abuse-deterrent properties
(June 2016)
11. Review new drug application, oxycodone hydrochloride and naltrexone hydrochloride extended-release
capsules, and abuse-deterrent properties (June 2016)
12. Review of biologics license application for brodalumab injection, a human monoclonal antibody for the
treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy
or phototherapy (July 2016)
13. Review of postmarketing-requirement randomized, placebo-controlled trial of the neuropsychiatric effects
of CHANTIX (varenicline), ZYBAN (buproprion), and nicotine replacement therapy and observational
studies to determine whether the findings support removal of the boxed warning or other changes to
product labeling (September 2016)
14. Review new drug application, oxycodone hydrochloride immediate-release tablets, and abuse-deterrent
properties (April 2017)
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Appendix B. Reach of Scientific Contributions
SELECTED EXAMPLES: INCORPORATION OF RESEARCH FINDINGS INTO SYSTEMATIC REVIEWS AND
CLINICAL RECOMMENDATIONS
Cervesi C, Park SY, Galling B, Molteni S, Masi G, Gerhard T, Olfson M, Correll CU. Extent, Time Course, and
Moderators of Antipsychotic Treatment in Youth With Mood Disorders: Results of a Meta-Analysis and Meta-
Regression Analyses. J Clin Psychiatry. 2017 Mar;78(3):347-357. doi: 10.4088/JCP.15r10435.
Dusetzina SB, Higashi AS, Dorsey ER, Conti R, Huskamp HA, Zhu S, Garfield CF, Alexander GC. Impact of
FDA drug risk communications on health care utilization and health behaviors: a systematic review. Med Care.
2012 Jun;50(6):466-78. doi: 10.1097/MLR.0b013e318245a160.
The Concannon et al. taxonomy for stakeholder engagement was referenced at the Patient-Centered Outcomes
Research Institute’s (PCORI) May Board of Governors meeting as a possible framework to guide PCORI’s
stakeholder engagement efforts. Cited in Avalere EBM Insights, June 4, 2012.
M. De Hert, D., Vancampfort, C.U. Correll, V. Mercken, J. Peuskens, K. Sweers, R. van Winkel, A. J. Mitchell.
“Guidelines for screening and monitoring of cardiometabolic risk in schizophrenia: systematic evaluation” The
British Journal of Psychiatry. 2011; 199: 99-105.
Agency for Healthcare Research and Quality (AHRQ) Effective Health Care Program. “Review of Off-Label Use
of Atypical Antipsychotics – Update.” March 21, 2011.
Clinical Context article cited in the Continuing Medical Education (CME) program “New Guidelines for Exercise
in Type 2 Diabetes from Medscape Education Clinical Briefs,” December 16, 2010
(http://www.medscape.org/viewarticle/734359). This CME activity reviews “Exercise and Type 2 Diabetes:
American College of Sports Medicine and the American Diabetes Association: Joint Position Statement”.
Medicine and Science in Sports and Exercise. 2010; 42(12):2282-2303.
Treatment in Psychiatry. Benedetto Vittiello and Jane L. Pearson. “A Depressed Adolescent at High Risk of
Suicidal Behavior”. Am J Psychiatry. 2008; 165(3); 323-328.
SELECTED EXAMPLES: MEDIA COVERAGE OF RESEARCH FINDINGS
Story. “Antipsychotic-Related Metabolic Testing Falls Far Short” MedScape. May 26, 2016.
Guest Appearance. Emmy Award-winning show The Doctors! Episode: Underage Habits That Turn Into Over-
Age Health Dilemmas! Story: New, FDA-Approved Weight Loss Drugs. Air date: October 16, 2012.
Feature Story. “Metabolic syndrome risk in patients prescribed atypical antipsychotics.” Psychiatric Annals.
2011; 41(7): 347-349.
Research Highlights. “Diabetes mellitus and periodontal disease in youth”. Nature Reviews Endocrinology.
2011; 7:7.
Cover Story. “Antipsychotic drug warnings indicate need for better communication between endocrinologists,
psychiatrists.” EndocrineToday. 2010; 8(6): 1, 10-12.
Story. “Are FDA Warnings on Antipsychotics Heeded?” Psychiatric Times. 2010; Vol 27, No. 4, April 7, 2010.
Medical News and Perspectives. “Questionable Antipsychotic Prescribing Remains Common, Despite Serious
Risks” JAMA. 2010; 303(16); 1582-1584.
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Medical News and Perspectives. “Studies Shed Light on Risks and Trends in Pediatric Antipsychotic
Prescribing” JAMA. 2010; 303(19); 1901-1903.
Editorial. Graham J. Emslie. “Improving Outcome in Pediatric Depression”. Am J Psychiatry. 2008; 165(1):1-3.
“Study looks at possible connection between periodontal disease and type 1 diabetes in children”, Practice
update, The Children’s Hospital (Denver, CO) Spring 2008; 8-9.
Story. “Medical Monitoring Often Missing from Care of Patients on SGAs”. Psychiatric News. 2008;
43(21): 2, 25.
Chase Squires (The Associated Press) “Study: Most Diabetics Don’t Exercise” appeared in The Washington Post.
USAToday. msnbc.com and other national news outlets. January 26, 2007.
Jorge Cruise. FitSmart Highlight. “Losing weight decreases diabetes risk”. USA Weekend. June 22-24, 2007.
Editorial. Cynthia R. Pfeffer. “The FDA Pediatric Advisories and Changes in Diagnosis and Treatment of
Pediatric Depression”. Am J Psychiatry. 2007; 164 (6); 843-846.
Tony Dokoupil. “Trouble in a ‘Black Box’ – Did an effort to reduce teen suicides backfire?” Newsweek.
July 16, 2007.
SELECTED PRESS COVERAGE: QUOTED CONTRIBUTIONS FROM FDA ADVISORY COMMITTEE HEARINGS
FDA Panel Backs Abuse-Deterrent Immediate-Release Opiod. MedPage Today-Apr 5, 2017.
Nix Box Warning on Smoking Cessation Drug, FDA Panel Says. Medscape-Sep 16, 2016
FDA Panel Splits on Softening Chantix Warning. MedPage Today-Sep 15, 2016
FDA Panel Backs Approval of Psoriasis Drug Broadalumab. Medscape-Jul 20, 2016
Psoriasis Drug Siliq Supported by FDA Panel Despite Suicide Risk. Psoriasis news Today-Jul 21, 2016
FDA Panel: Physician Opioid Training Should be Mandatory. Medscape-May 6, 2016
Novel Opioid Not Abuse-Deterrent, FDA Panel Says. MedPage Today-May 6, 2016
Cystic Fibrosis Drug Wins Approval of FDA Advisory Panel. New York Times-May 12, 2015
Cover Story. “Experts call for improved FDA Risk Evaluation and Mitigation Strategy Program”
EndocrineToday. 2014; 1
FDA Panel Split on Safety of Long-Acting Testosterone. Medscape-Apr 18, 2013
FDA panel backs obesity pill Qnexa: What happens next? CBS News-Feb 23, 2012
Qnexa Gains FDA Panel Backing: Facts on and Side Effects of the Newest Weight-Loss Drug. International
Business Times-Feb 23, 2012
Drospirenone Contraceptives Worth the Risk: FDA Panel – Medscape-Dec 9, 2011
FDA Panel Votes to Restrict Avandia. New York Times (blog)-Jul 14, 2010